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amoxicillin and clavulanate potassium 250 mg/5mL; 62.5 mg/5mL Powder, For Suspension, 75 mL — NDC 73043-0010-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

amoxicillin and clavulanate potassium 250 mg/5mL; 62.5 mg/5mL Powder, For Suspension, 75 mL — NDC 73043-010-01 (Billing 73043-0010-01)

by Devatis, Inc. · 75 mL in 1 BOTTLE

This is a package of 75 mL of amoxicillin and clavulanate potassium 250 mg/5mL; 62.5 mg/5mL Powder, For Suspension from Devatis, Inc., marketed since Jul 2024 and currently FDA-listed; retail pharmacies pay about $0.4354 per mL (NADAC).

NDC 73043-0010-01
🏷️ FDA NDC (as labeled) 73043-010-01 billing pads the product segment with a zero
This package
Contains75 mL Cost per mL$0.4354 NADAC Per package$32.66 / 75 ml Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.6154/unit · Part D plans $0.4412/unit — full pricing hub ↓
Product page 73043-0010-02 Also comes in: 100 ml 73043-010-02 150 ml 73043-010-03
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 73043-010-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
73043 labeler · 010 product · 01 package
Package marketed since
Aug 15, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
75 mL per package
Barcode (UPC-A, from the NDC)
3 7304301001 6
Medicaid fills, this package
826 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 73043-010-01
Product NDC 73043-010
11-digit billing NDC 73043001001
NCPDP billing unit ML — per mL (volume)
RxCUI 617322
UNII 804826J2HU, Q42OMW3AT8
Application # ANDA210374
SPL Set ID b0b2e164-e70d-471f-92ce-abdac6cb405f
Established class (EPC) Penicillin-class Antibacterial; beta Lactamase Inhibitor
Mechanism of action beta Lactamase Inhibitors
Chemical class Penicillins
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-07-05
Route ORAL
Dosage form POWDER, FOR SUSPENSION
Substance AMOXICILLIN; CLAVULANATE POTASSIUM
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 01990002201920
GCN Seq No 008990
GCN 67151
HICL code 003962
Ingredient (HICL) Amoxicillin/Potassium Clav
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1A
Therapeutic class — specific (HIC3) Penicillin Antibiotics
AHFS code 08:12.16.08
AHFS class Aminopenicillin Antibiotics
FDB label name AMOX-CLAV 250-62.5 MG/5 ML SUS
FDB brand name Amoxicillin-Clavulanate Potass
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 008990
  • GCN: 67151
  • GPI-14 (Medi-Span): 01990002201920
  • HICL (First Databank): 003962
  • AHFS class code: 08:12.16.08
  • RxCUI (RxNorm): 617322
Why two NDCs? The FDA registers this code as 73043-010-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 73043-0010-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the beta Lactamase Inhibitor class.

Pharmacologic class beta Lactamase Inhibitor
How it works beta Lactamase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name AMOX-CLAV 250-62.5 MG/5 ML SUS Ingredient Amoxicillin/Potassium Clav
📖 What it is MedlinePlus · NLM

Amoxicillin and clavulanic acid is used to treat certain infections caused by bacteria, including infections of the ears, lungs, sinus, skin, and urinary tract. Amoxicillin is in a class of medications called penicillin-like antibiotics. It works by stopping the growth of bacteria. Clavulanic acid is in a class of medications called beta-lactamase inhibitors. It works by stopping bacteria from breaking down amoxicillin. Antibiotics will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists a...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats bacterial infections such as those of the lungs, sinuses, ears, skin and urinary tract. Some forms are for specific infections, like middle ear infections in young childr...
  • You can take it with or without food. But taking it at the start of a meal helps you absorb the clavulanate and often eases stomach upset. Follow your prescriber's directions for y...
  • Diarrhea, loose stools, nausea and mild rash are the most common. Vomiting and vaginal yeast infections can also happen. Call us if symptoms are severe or don't settle.
  • Get urgent help for trouble breathing, swelling, hives or a spreading or blistering rash. Call your doctor if you have yellow skin or eyes, or watery or bloody diarrhea, even weeks...
📖 Read our full Amoxicillin / Clavulanate guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $0.435 $32.66 / 75 ml
Medicaid paysCMS SDUD · 12 mo $0.6154 $46.16 / 75 ml
Medicare drug plans payPart D · Q2 2026 $0.4412 $33.09 / 75 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.492 $0.432
▼ Down 8% over the last 10 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
73043-0010-01 You're viewing this 75 mL in 1 BOTTLE $0.4354 / mL $32.65 2024-08-15 — Active
73043-0010-02 73043-010-02 Main listing 100 mL in 1 BOTTLE $0.4551 / mL $45.51 2024-09-01 — Active
73043-0010-03 73043-010-03 150 mL in 1 BOTTLE $0.3920 / mL $58.81 2024-07-05 — Active

You're viewing the smallest of 3 pack sizes for this product.

Per mL, this pack runs about 11% above the cheapest pack (150 mL, $0.3920 vs $0.4354 NADAC).

This pack accounts for about 26% of this product's recent Medicaid fills; the largest share goes to the 100 ml pack. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 75 mL — 75 ml in 1 bottle.
How does this package differ from NDC 73043-0010-02?
Both are amoxicillin and clavulanate potassium 250 mg/5mL; 62.5 mg/5mL Powder, For Suspension — the drug itself is identical. This page's package is the 75 mL one, while NDC 73043-0010-02 is the 100 ml package. Per-mL NADAC also differs: $0.4354 here vs $0.4551 for the 100 ml pack.
What NDC number is used to bill for this package of amoxicillin and clavulanate potassium 250 mg/5mL; 62.5 mg/5mL Powder, For Suspension?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Amoxicillin and Clavulanate potassium 250 mg/5mL; 62.5 mg/5mL 69097-0098-08 Cipla 150 ml $0.392 AB Availability likely save 10%
amoxicillin and clavulanate potassium 250 mg/5mL; 62.5 mg/5mLthis 73043-0010-01 Devatis, 75 ml $0.435 AB Availability likely —
Amoxicillin And Clavulanate Potassium 250 mg/5mL; 62.5 mg/5mL 81964-0204-07 USAntibiotics, 75 ml $0.435 AB Availability likely —
Amoxicillin and Clavulanate Potassium 250 mg/5mL; 62.5 mg/5mL 59651-0026-01 Aurobindo 100 ml $0.455 AB Availability likely +5%
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2024
On the market since
Jul 2024
📍
2026
Currently FDA-listed
2 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color White
FlavorVanilla
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Amoxicillin / Clavulanate inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII K4WBE45SCM
    A chemical compound used as a flavoring agent and solvent in medications. It helps dissolve active ingredients and adds taste to make medicines more palatable.
  • UNII Q40Q9N063P
    Acetic acid is a weak organic acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level to ensure the drug remains stable and effective in its formulation.
  • UNII BG4D34CO2H
    Acetoin is a synthetic organic compound used in medicines as a flavoring agent and fragrance component. It gives products a butter or cream-like taste and smell to make them more palatable.
  • UNII 3VH84A363D
    Allyl hexanoate is a synthetic fragrance compound used as a flavoring agent in medicines. It provides fruity or pineapple-like taste notes to mask unpleasant flavors in oral formulations.
  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII 7N6XGV3U49
    Anisyl alcohol is an organic compound with a pleasant aromatic scent. It's used in medicines as a fragrance or flavoring agent to improve taste or smell, and may also help as a preservative or solvent in liquid formulations.
  • UNII DIK0395679
    A fragrant resin extracted from South American balsam trees. It's used as a flavoring agent and fragrance in medicines to mask unpleasant tastes or smells.
  • UNII 8KD59RC90V
    A natural plant resin derivative used as a preservative and antimicrobial agent. It helps prevent bacterial and fungal growth, extending the product's shelf life and stability.
  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII 05JZI7B19X
    A plant-based thickener made from cellulose that holds water and creates texture. It works as a binder and thickening agent to give the medicine its proper consistency and help ingredients blend together.
  • UNII T7EU0O9VPP
    Citral is a natural oil compound found in lemon and citrus plants. It's used in medicines as a flavoring agent and to add pleasant lemon or citrus scent to the product.
  • UNII 1JJT408R87
    A naturally derived organic acid used in medicines as a buffer and pH regulator. It helps maintain the proper acidity level so the medication stays stable and effective in its dosage form.
  • UNII 9X45FJL446
    A fragrance compound derived from natural sources, used to provide pleasant smell and taste to medicines. It helps mask unpleasant flavors and improves the overall palatability of the product.
  • UNII D9108TZ9KG
    Cocoa is a natural powder made from roasted cacao beans. It's used as a flavoring and coloring agent to make medicines taste better and appear brown.
  • UNII 59VBP7Z87U
    A synthetic oily liquid derived from decanoic acid, used in medicines as a solvent and penetration enhancer to help active ingredients dissolve and absorb effectively in the formulation.
  • UNII UFD2LZ005D
    Ethyl butyrate is a synthetic flavoring compound that smells fruity and buttery. It's added to medicines to improve taste and mask unpleasant flavors, making them easier to take.
  • UNII 2NK7O363Q6
    Fusel oil is a byproduct of alcohol fermentation, containing various organic compounds. It's used in medicines as a flavoring agent and solvent to improve taste and help dissolve active ingredients.
  • UNII L837108USY
    Geraniol is a natural fragrant compound found in plants like roses and lemons. It's used in medicines as a flavoring agent and to improve the taste or aroma of the product.
  • UNII O05EC62663
    A natural oil derived from glycerin and oleic acid. It acts as a lubricant and emollient in medicines, helping ingredients mix smoothly and improving how the product flows during manufacturing and application.
  • UNII Z135787824
    Isoamyl acetate is a synthetic ester chemical that gives off a banana-like scent. It's used as a flavoring agent and fragrance component in medicines to improve taste and smell.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII H74221J5J4
    Myrrh oil is a fragrant resin extracted from myrrh tree bark. It is used in medicines as a flavoring agent and to add aroma or taste to the product.
  • UNII OBL58JN025
    Octanoic acid is a fatty acid used as a solvent and surfactant in medicines. It helps dissolve active ingredients and improve how the body absorbs them.
  • UNII AKN3KSD11B
    Orange oil obtained by cold pressing orange peel. It serves as a flavoring agent and fragrance in medicines to improve taste and aroma.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • UNII R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
  • UNII CHI530446X
    Vanillin is a natural or synthetic aromatic compound that gives vanilla flavor. It's used in medicines as a flavoring agent to mask bitter tastes and improve how the medicine tastes.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

34 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerDevatis, Inc.
Application holderDEVA HOLDING AS
FDA applicationANDA210374 (ANDA)
Labeler code73043
First marketedJul 2024
Product typeHuman Prescription Drug
Portfolio16 products on file

More NDCs from Devatis, Inc. labeler code 73043

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE Amoxicillin and clavulanate potassium for oral suspension is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: Lower Respiratory Tract Infections - caused by beta-lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis . Acute Bacterial Otitis Media – caused by beta-lactamase-producing isolates of H. influenzae and M. catarrhalis. Sinusitis - caused by beta-lactamase–producing isolates of H. influenzae and M. catarrhalis .

Skin and Skin Structure Infections - caused by beta-lactamase–producing isolates of Staphylococcus aureus, Escherichia coli , and Klebsiella species. Urinary Tract Infections - caused by beta-lactamase–producing isolates of E. coli, Klebsiella species, and Enterobacter species. Limitations of Use When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, Amoxicillin and clavulanate potassium for oral suspension should not be used.

Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and clavulanate potassium for oral suspension and other antibacterial drugs, Amoxicillin and clavulanate potassium for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Amoxicillin and Clavulanate Potassium for Oral Suspension is a combination of amoxicillin, a penicillin-class antibacterial and clavulanate potassium, a beta-lactamase inhibitor indicated for treatment of the following infections in adults and pediatric patients: ( 1 ) Lower respiratory tract infections Acute bacterial otitis media Sinusitis Skin and skin structure infections Urinary tract infections Limitations of Use When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, Amoxicillin and clavulanate potassium for oral suspension should not be used.

( 1 ) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and clavulanate potassium for oral suspension and other antibacterial drugs, Amoxicillin and clavulanate potassium for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Adults and Pediatric Patients greater than 40 kg: 500 or 875 mg every 12 hours or 250 or 500 mg every 8 hours, based on amoxicillin component. ( 2.2 , 2.3 ) Pediatric patients aged 12 weeks (3 months) and older: 25 to 45 mg/kg/day every 12 hours or 20 to 40 mg/kg/day every 8 hours, up to the adult dose. ( 2.3 ) Neonates and infants less than 12 weeks of age: 30 mg/kg/day divided every 12 hours, based on the amoxicillin component.

Use of the 125 mg/5 mL oral suspension is recommended. ( 2.3 )

2.1Important Administration Instructions Amoxicillin and clavulanate potassium for oral suspension may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and clavulanate potassium for oral suspension is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and clavulanate potassium for oral suspension should be taken at the start of a meal.

2.2Adults See dosing regimens of Amoxicillin and clavulanate potassium for oral suspension (based on the amoxicillin component) provided in Table 1 below. Table 1. Dosing Regimens of Amoxicillin and Clavulanate Potassium for Oral Suspension in Adult Patients TYPE OF INFECTION DOSING REGIMEN OF AMOXICILLIN AND CLAVULANATE POTASSIUM Severe infections and infections of the respiratory tract one 875 mg tablet Adults who have difficulty swallowing may be given the Amoxicillin and clavulanate potassium 200 mg/28.5 mg per 5 mL suspension or the Amoxicillin and clavulanate potassium 400 mg/57 mg per 5 mL suspension may be used in place of the AUGMENTIN 875 mg/125 mg tablet. of AUGMENTIN every 12 hours or one 500 mg tablet Adults who have difficulty swallowing may be given the Amoxicillin and clavulanate potassium 125 mg/31.25 mg per 5 mL or Amoxicillin and clavulanate potassium 250 mg/62.5 mg per 5 mL suspension in place of the AUGMENTIN 500 mg/125 mg tablet.

Two AUGMENTIN 250 mg/125 mg tablets are NOT substitutable with one 500 mg/125 mg AUGMENTIN tablet [ see Dosage and Administration ( 2.6 ) ] of AUGMENTIN every 8 hours Less severe infections one 500 mg tablet , of AUGMENTIN every 12 hours or one 250 mg tablet AUGMENTIN 250 mg/125 mg tablet is NOT substitutable with AUGMENTIN 250 mg/62.5 mg chewable tablet [ see Dosage and Administration ( 2.6 ) ]. of AUGMENTIN every 8 hours

2.3Pediatric Patients Based on the amoxicillin component, Amoxicillin and clavulanate potassium should be dosed as follows: Neonates and Infants Aged less than 12 weeks (less than 3 months) : See dosing regimens of Amoxicillin and clavulanate potassium provided in Table 2 below. Table 2: Dosing Regimens of Amoxicillin and clavulanate potassium in Neonates and Infants Aged Less than 12 Weeks (Less than 3 Months) PATIENT POPULATION DOSING REGIMEN Amoxicillin and clavulanate potassium 125 mg/31.25 mg per 5 mL for oral suspension Experience with the Amoxicillin and clavulanate potassium 200 mg/28.5 mg per 5 mL formulation in this age group is limited, and thus, use of the Amoxicillin and clavulanate potassium 125 mg/31.25 mg per 5 mL for oral suspension is recommended.

Neonates and Infants aged less than 12 weeks (less than 3 months) 30 mg/kg/day every 12 hours Patients Aged 12 weeks (3 months) and Older and Weighing Less than 40 kg: See dosing regimens provided in Table 3 below.· The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [ see Clinical Studies ( 14.2 ) ]. Table 3: Dosing in Patients Aged 12 weeks (3 Months) and Older and Weighing Less than 40 kg INFECTION DOSING REGIMEN Every 12 hours Every 8 hours Amoxicillin and clavulanate potassium 200 mg/28.5 mg per 5 mL or Amoxicillin and clavulanate potassium 400 mg/57 mg per 5 mL for oral suspension Each strength of Amoxicillin and clavulanate potassium for oral suspension is available as an AUGMENTIN chewable tablet for use by older children.

Amoxicillin and clavulanate potassium 125 mg/31.25 mg per 5 mL or… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 54 words ▾

3 DOSAGE FORMS AND STRENGTHS Amoxicillin and Clavulanate Potassium Powder for Oral Suspension, USP: 250 mg/62.5 mg per 5 mL: Vanilla-odored powder for oral suspension (each 5 mL of reconstituted suspension contains 250 mg amoxicillin and 62.5 mg clavulanic acid as the potassium salt). For Oral Suspension: 250 mg/62.5 mg per 5 mL (3)

⛔ Contraindications 121 words ▾

4 CONTRAINDICATIONS History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to Amoxicillin and Clavulanate Potassium for Oral Suspension or to other beta-lactams (e.g., penicillins or cephalosporins). ( 4.1 ) History of cholestatic jaundice/hepatic dysfunction associated with Amoxicillin and Clavulanate Potassium for Oral Suspension ( 4.2 )

4.1Serious Hypersensitivity Reactions Amoxicillin and Clavulanate Potassium for Oral Suspension is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin, clavulanate or to other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins).

4.2Cholestatic Jaundice/Hepatic Dysfunction Amoxicillin and Clavulanate Potassium for Oral Suspension is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with Amoxicillin and Clavulanate Potassium for Oral Suspension.

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Serious (including fatal) hypersensitivity reactions: Discontinue Amoxicillin and Clavulanate Potassium for Oral Suspension if a reaction occurs. ( 5.1 ) Severe Cutaneous Adverse Reactions (SCAR): Monitor closely. Discontinue if rash progresses.

( 5.2 ) Drug-induced enterocolitis syndrome (DIES) has been reported with use of amoxicillin, a component of Amoxicillin and Clavulanate Potassium for Oral Suspension. If this occurs, discontinue Amoxicillin and Clavulanate Potassium for Oral Suspension and institute appropriate therapy. ( 5.3 ) Hepatic dysfunction and cholestatic jaundice: Discontinue if signs/symptoms of hepatitis occur.

Monitor liver function tests in patients with hepatic impairment. ( 5.4 ) Clostridioides difficile -associated diarrhea (CDAD): Evaluate patients if diarrhea occurs. ( 5.5 ) Patients with mononucleosis who receive Amoxicillin and Clavulanate Potassium for Oral Suspension develop skin rash.

Avoid Amoxicillin and Clavulanate Potassium for Oral Suspension use in these patients. ( 5.6 ) Overgrowth: The possibility of superinfections with fungal or bacterial pathogens should be considered during therapy. ( 5.7 )

5.1Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterials, including Amoxicillin and Clavulanate Potassium for Oral Suspension. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. Before initiating therapy with Amoxicillin and Clavulanate Potassium for Oral Suspension, careful inquiry should be made regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens.

If an allergic reaction occurs, Amoxicillin and Clavulanate Potassium for Oral Suspension, should be discontinued, and appropriate therapy instituted.

5.2Severe Cutaneous Adverse Reactions Amoxicillin and clavulanate potassium may cause severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If patients develop a skin rash, they should be monitored closely, and Amoxicillin and clavulanate potassium discontinued if lesions progress.

5.3Drug-Induced Enterocolitis Syndrome (DIES) Drug-induced enterocolitis syndrome (DIES) has been reported with use of amoxicillin, a component of Amoxicillin and Clavulanate Potassium for Oral Suspension [ see Adverse Reactions ( 6.2 ) ], with most cases occurring in pediatric patients ≤ 18 years of age. DIES is a non-IgE mediated hypersensitivity reaction characterized by protracted vomiting occurring 1 to 4 hours after drug ingestion in the absence of skin or respiratory symptoms. DIES may be associated with pallor, lethargy, hypotension, shock, diarrhea within 24 hours of ingesting amoxicillin, and leukocytosis with neutrophilia.

If DIES occurs, discontinue Amoxicillin and Clavulanate Potassium for Oral Suspension and institute appropriate therapy.

5.4Hepatic Dysfunction Hepatic dysfunction, including hepatitis and cholestatic jaundice has been associated with the use of Amoxicillin and Clavulanate Potassium for Oral Suspension. Hepatic toxicity is usually reversible; however, deaths have been reported. Hepatic function should be monitored at regular intervals in patients with hepatic impairment.

5.4Clostridium difficile Associated Diarrhea (CDAD) Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Amoxicillin and Clavulanate Potassium for Oral Suspension, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: Anaphylactic reactions [see Warnings and Precautions ( 5.1 )] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.2 )] Hepatic Dysfunction [see Warnings and Precautions ( 5.3 )] Clostridioides difficile Associated Diarrhea (CDAD) [see Warnings and Precautions ( 5.4 )] The most frequently reported adverse effects were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%),vomiting (1%) and vaginitis (1%) (6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Devatis Inc. at 1-833-534-4406 or [email protected] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch or www.devatis.com.

6.1Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most frequently reported adverse reactions were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%). Less than 3% of patients discontinued therapy because of drug-related adverse reactions.

The overall incidence of adverse reactions, and in particular diarrhea, increased with the higher recommended dose. Other less frequently reported adverse reactions (less than 1%) include: Abdominal discomfort, flatulence, and headache. In pediatric patients (aged 2 months to 12 years), 1 US/Canadian clinical trial was conducted which compared 45/6.4 mg/kg/day (divided every 12 hours) of AUGMENTIN for 10 days versus 40/10 mg/kg/day (divided every 8 hours) of AUGMENTIN for 10 days in the treatment of acute otitis media.

A total of 575 patients were enrolled, and only the suspension formulations were used in this trial. Overall, the adverse reactions seen were comparable to that noted above; however, there were differences in the rates of diarrhea, skin rashes/urticaria, and diaper area rashes [See Clinical Studies (14.2) ]

6.2Postmarketing Experience In addition to adverse reactions reported from clinical trials, the following have been identified during postmarketing use of AUGMENTIN. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to AUGMENTIN.

Gastrointestinal: Indigestion, gastritis, stomatitis, glossitis, black “hairy” tongue, mucocutaneous candidiasis, enterocolitis, and hemorrhagic/pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment [see Warnings and Precautions ( 5.5 )]. Immune: Hypersensitivity reactions, anaphylactic/anaphylactoid reactions (including shock), angioedema, serum sickness-like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), hypersensitivity vasculitis [see Warnings and Precautions ( 5.1 )].

Skin and Appendages: Rashes, pruritus, urticaria, erythema multiforme, SJS, TEN, DRESS, AGEP, exfoliative dermatitis and linear IgA bullous dermatosis. Liver: Hepatic dysfunction, including hepatitis and cholestatic jaundice, increases in serum transaminases (AST and/or ALT), serum bilirubin, and/or alkaline phosphatase, has been reported with AUGMENTIN. It has been reported more commonly in the elderly, in males, or in patients on prolonged treatment.

The histologic findings on liver biopsy have consisted of predominantly cholestatic, hepatocellular, or mixed cholestatic hepatocellular changes. The onset of signs/symptoms of hepatic dysfunction may occur during or several weeks after therapy has been discontinued. The hepatic dysfunction, which may be severe, is usually reversible.

Deaths have been reported [see Contraindications ( 4.2 ), Warnings and Precaut… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Co‑administration with probenecid is not recommended. (7.1) Concomitant use of Amoxicillin and Clavulanate Potassium for Oral Suspension and oral anticoagulants may increase the prolongation of prothrombin time. (7.2 ) Coadministration with allopurinol increases the risk of rash. (7.3) Amoxicillin and Clavulanate Potassium for Oral Suspension may reduce efficacy of oral contraceptives. (7.4)

7.1Probenecid Probenecid decreases the renal tubular secretion of amoxicillin but does not delay renal excretion of clavulanic acid. Concurrent use with Amoxicillin and clavulanate potassium may result in increased and prolonged blood concentrations of amoxicillin. Co-administration of probenecid is not recommended.

7.2Oral Anticoagulants Abnormal prolongation of prothrombin time (increased international normalized ratio [INR]) has been reported in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently with Amoxicillin and clavulanate potassium. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.

7.3Allopurinol The concurrent administration of allopurinol and amoxicillin increases the incidence of rashes in patients receiving both drugs as compared to patients receiving amoxicillin alone. It is not known whether this potentiation of amoxicillin rashes is due to allopurinol or the hyperuricemia present in these patients.

7.4Oral Contraceptives Amoxicillin and clavulanate potassium may affect intestinal flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.

7.5Effects on Laboratory Tests High urine concentrations of amoxicillin may result in false-positive reactions when testing for the presence of glucose in urine using CLINITEST®, Benedict’s Solution, or Fehling’s Solution. Since this effect may also occur with Amoxicillin and clavulanate potassium, it is recommended that glucose tests based on enzymatic glucose oxidase reactions be used. Following administration of amoxicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pediatric Use: Modify dose in patients 12 weeks or younger. (8.4) Renal impairment; Dosage adjustment is recommended for severe renal impairment (GFRless than 30mL/min). ( 2.4 , 8.6 )

8.1Pregnancy Teratogenic Effects : Pregnancy Category B. Reproduction studies performed in pregnant rats and mice given AUGMENTIN (2:1 ratio formulation of amoxicillin:clavulanate) at oral doses up to 1200 mg/kg/day revealed no evidence of harm to the fetus due to AUGMENTIN. The amoxicillin doses in rats and mice (based on body surface area) were approximately 4 and 2 times the maximum recommended adult human oral dose (875 mg every 12 hours).

For clavulanate, these dose multiples were approximately 9 and 4 times the maximum recommended adult human oral dose (125 mg every 8 hours). There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

8.2Labor and Delivery Oral ampicillin-class antibacterials are poorly absorbed during labor. It is not known whether use of amoxicillin and clavulanate potassium in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood of the necessity for an obstetrical intervention.

8.3Nursing Mothers Amoxicillin has been shown to be excreted in human milk. Amoxicillin and clavulanate potassium use by nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin and clavulanate potassium is administered to a nursing woman.

8.4Pediatric Use The safety and effectiveness of AUGMENTIN for Oral Suspension and Chewable Tablets have been established in pediatric patients. Use of AUGMENTIN in pediatric patients is supported by evidence from studies of AUGMENTIN Tablets in adults with additional data from a study of AUGMENTIN for Oral Suspension in pediatric patients aged 2 months to 12 years with acute otitis media [see Clinical Studies (14.2 )] Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed; clavulanate elimination is unaltered in this age group.

Dosing of Amoxicillin and clavulanate potassium should be modified in pediatric patients aged less than 12 weeks (less than 3 months) [see Dosage and Administration (2.3 ) ]

8.5Geriatric Use Of the 3,119 patients in an analysis of clinical studies of AUGMENTIN, 32% were greater than or equal to 65 years old, and 14% were greater than or equal to 75 years old. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

8.6Renal Impairment Amoxicillin is primarily eliminated by the kidney and dosage adjustment is usually required in patients with severe renal impairment (GFR less than 30 mL/min). See Patients with Renal Impairment [see Dosage and Administration ( 2.4 )] for specific recommendations in patients with renal impairment.

🤰 Pregnancy 127 words ▾

8.1Pregnancy Teratogenic Effects : Pregnancy Category B. Reproduction studies performed in pregnant rats and mice given AUGMENTIN (2:1 ratio formulation of amoxicillin:clavulanate) at oral doses up to 1200 mg/kg/day revealed no evidence of harm to the fetus due to AUGMENTIN. The amoxicillin doses in rats and mice (based on body surface area) were approximately 4 and 2 times the maximum recommended adult human oral dose (875 mg every 12 hours).

For clavulanate, these dose multiples were approximately 9 and 4 times the maximum recommended adult human oral dose (125 mg every 8 hours). There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 121 words ▾

8.4Pediatric Use The safety and effectiveness of AUGMENTIN for Oral Suspension and Chewable Tablets have been established in pediatric patients. Use of AUGMENTIN in pediatric patients is supported by evidence from studies of AUGMENTIN Tablets in adults with additional data from a study of AUGMENTIN for Oral Suspension in pediatric patients aged 2 months to 12 years with acute otitis media [see Clinical Studies (14.2 )] Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed; clavulanate elimination is unaltered in this age group.

Dosing of Amoxicillin and clavulanate potassium should be modified in pediatric patients aged less than 12 weeks (less than 3 months) [see Dosage and Administration (2.3 ) ]

🧓 Geriatric Use 135 words ▾

8.5Geriatric Use Of the 3,119 patients in an analysis of clinical studies of AUGMENTIN, 32% were greater than or equal to 65 years old, and 14% were greater than or equal to 75 years old. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

🆘 Overdosage 160 words ▾

10 OVERDOSAGE In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures as required. A prospective study of 51 pediatric patients at a poison-control center suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms1. Interstitial nephritis resulting in oliguric renal failure has been reported in patients after overdosage with amoxicillin and clavulanate potassium.

Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin and clavulanate potassium overdosage in adult and pediatric patients. In case of overdosage, adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin and clavulanate potassium crystalluria. Renal impairment appears to be reversible with cessation of drug administration.

High blood levels may occur more readily in patients with impaired renal function because of decreased renal clearance of amoxicillin and clavulanate potassium. Amoxicillin and clavulanate potassium may be removed from circulation by hemodialysis [see Dosage and Administration ( 2.4 )].

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Amoxicillin and clavulanate potassium is an antibacterial drug. [see Microbiology 12.4 ]

12.3Pharmacokinetics Mean amoxicillin and clavulanate potassium pharmacokinetic parameters in normal adults following administration of AUGMENTIN Tablets are shown in Table 6 and following administration of AUGMENTIN for Oral Suspension and Chewable Tablets are shown in Table 7. Table 6: Mean (±S.D.) Amoxicillin and Clavulanate Potassium Pharmacokinetic Parameters a,b with Amoxicillin and Clavulanate Potassium Tablets Dose and Regimen of AUGMENTIN C max (mcg/mL) AUC 0-24 (mcg*h/mL) Amoxicillin and Clavulanate potassium Amoxicillin Clavulanate potassium Amoxicillin Clavulanate potassium 250/125 mg every 8 hours 3.3 ± 1.12 1.5 ± 0.70 26.7 ± 4.56 12.6 ± 3.25 500/125 mg every 12 hours 6.5 ± 1.41 1.8 ± 0.61 33.4 ± 6.76 8.6 ± 1.95 500 125 mg every 8 hours 7.2 ± 2.26 2.4 ± 0.83 53.4 ± 8.87 15.7 ± 3.86 875/125 mg every 12 hours 11.6 ± 2.78 2.2 ± 0.99 53.5 ± 12.31 10.2 ± 3.04 a Mean (± standard deviation) values of 14 normal adults (N=15 for clavulanate potassium in the low-dose regimens).

Peak concentrations occurred approximately 1.5 hours after the dose. b Amoxicillin/clavulanate potassium administered at the start of a light meal. Table 7: Mean (±S.D.) Amoxicillin and Clavulanate Potassium Pharmacokinetic Parameters a,b with Amoxicillin and Clavulanate Potassium Powder for Oral Suspension and Chewable Tablets Dose of AUGMENTIN C max (mcg/mL) AUC 0-24 (mcg*h/mL) Amoxicillin and Clavulanate potassium Amoxicillin Clavulanate potassium Amoxicillin Clavulanate potassium 400/57 mg(5 mL of suspension) 6.94 ± 1.24 1.10 ± 0.42 17.29 ± 2.28 2.34 ± 0.94 400/57 mg(1 chewable tablet) 6.67 ± 1.37 1.03 ± 0.33 17.24 ± 2.64 2.17 ± 0.73 a Mean (± standard deviation) values of 28 normal adults.

Peak concentrations occurred approximately 1 hour after the dose. b Amoxicillin/clavulanate potassium administered at the start of a light meal. Oral administration of 5 mL of the 250 mg/62.5 mg suspension of AUGMENTIN or the equivalent dose of 10 mL of the 125 mg/31.25 mg suspension of AUGMENTIN provides average peak serum concentrations approximately 1 hour after dosing of 6.9 mcg/mL for amoxicillin and 1.6 mcg/mL for clavulanic acid. The areas under the serum concentration curves obtained during the first 4 hours after dosing were 12.6 mcg*h/mL for amoxicillin and 2.9 mcg*h/mL for clavulanic acid when 5 mL of the 250 mg/62.5 mg suspension of AUGMENTIN or equivalent dose of 10 mL of the 125 mg/31.25 mg suspension of AUGMENTIN were administered to normal adults.

One 250 mg/62.5 mg chewable tablet of AUGMENTIN or two 125 mg/31.25 mg chewable tablets of AUGMENTIN are equivalent to 5 mL of the 250 mg/62.5 mg suspension of AUGMENTIN and provide similar serum concentrations of amoxicillin and clavulanic acid. Amoxicillin serum concentrations achieved with AUGMENTIN are similar to those produced by the oral administration of equivalent doses of amoxicillin alone. Time above the minimum inhibitory concentration of 1 mcg/mL for amoxicillin has been shown to be similar after corresponding every 12 hour and every 8-hour dosing regimens of AUGMENTIN in adults and children.

Absorption: Dosing in the fasted or fed state has minimal effect on the pharmacokinetics of amoxicillin. While AUGMENTIN can be given without regard to meals, absorption of clavulanate potassium when taken with food is greater relative to the fasted state. In one study, the relative bioavailability of clavulanate was reduced when AUGMENTIN was dosed at 30 and 150 minutes after the start of a high-fat breakfast.

Distribution: Neither component in AUGMENTIN is highly protein-bound; clavulanic acid is approximately 25% bound to human serum and amoxicillin approximately 18% bound. Amoxicillin diffuses readily into most body tissues and fluids with the exception of the brain and spinal fluid. Two hours after oral administration of a single 35 mg/kg dose of suspension o… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 16 words ▾

12.1Mechanism of Action Amoxicillin and clavulanate potassium is an antibacterial drug. [see Microbiology 12.4 ]

📦 How Supplied / Storage and Handling 113 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Amoxicillin and Clavulanate Potassium for Oral Suspension, USP: 250 mg/62.5 mg per 5 mL is a white to creamy white colored, vanilla odored, homogeneous powder mixture – each 5 mL of reconstituted white to creamy white colored, vanilla odored homogeneous suspension contains 250 mg amoxicillin and 62.5 mg clavulanic acid as the potassium salt. NDC 73043 010 01 75 mL NDC 73043 010 02 100 mL NDC 73043 010 03 150 mL Dispense in original container. Store dry powder at20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Store reconstituted suspension under refrigeration.

Discard unused suspension after 10 days. Keep out of the reach of children.

📋 Description ~1 min read ▾

11 DESCRIPTION Amoxicillin and Clavulanate Potassium for Oral Suspension, USP is an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C 16 H 19 N 3 O 5 S•3H 2 O, and the molecular weight is 419.46.

Chemically, amoxicillin is (2 S, 5 R, 6 R )-6-[( R )-(-)-2-Amino-2-( p- hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as: Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus . It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C 8 H 8 KNO 5 , and the molecular weight is 237.25.

Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as: Each 5 mL of oral suspension contains 250 mg of amoxicillin as the trihydrate, and 62.5 mg of clavulanic acid (equivalent to 74.5 mg of clavulanate potassium). Each 5 mL of reconstituted amoxicillin and clavulanate potassium for oral suspension USP, 250 mg/62.5 mg per 5 mL contains 0.31 mEq of potassium and 0.12 mEq of sodium. Inactive Ingredients: Microcrystalline Cellulose and Carboxymethylcellulose Sodium, Sucralose, Sodium Citrate, Anhydrous Citric Acid, Silicon Dioxide, Colloidal Silicon Dioxide, Mannitol, Xanthan Gum, Vanilla Flavor, Tutti Frutti Flavor.

Amoxicillin Structure Clavulanate Potassium Structure

🍼 Nursing Mothers 42 words ▾

8.3Nursing Mothers Amoxicillin has been shown to be excreted in human milk. Amoxicillin and clavulanate potassium use by nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin and clavulanate potassium is administered to a nursing woman.

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Mean amoxicillin and clavulanate potassium pharmacokinetic parameters in normal adults following administration of AUGMENTIN Tablets are shown in Table 6 and following administration of AUGMENTIN for Oral Suspension and Chewable Tablets are shown in Table 7. Table 6: Mean (±S.D.) Amoxicillin and Clavulanate Potassium Pharmacokinetic Parameters a,b with Amoxicillin and Clavulanate Potassium Tablets Dose and Regimen of AUGMENTIN C max (mcg/mL) AUC 0-24 (mcg*h/mL) Amoxicillin and Clavulanate potassium Amoxicillin Clavulanate potassium Amoxicillin Clavulanate potassium 250/125 mg every 8 hours 3.3 ± 1.12 1.5 ± 0.70 26.7 ± 4.56 12.6 ± 3.25 500/125 mg every 12 hours 6.5 ± 1.41 1.8 ± 0.61 33.4 ± 6.76 8.6 ± 1.95 500 125 mg every 8 hours 7.2 ± 2.26 2.4 ± 0.83 53.4 ± 8.87 15.7 ± 3.86 875/125 mg every 12 hours 11.6 ± 2.78 2.2 ± 0.99 53.5 ± 12.31 10.2 ± 3.04 a Mean (± standard deviation) values of 14 normal adults (N=15 for clavulanate potassium in the low-dose regimens).

Peak concentrations occurred approximately 1.5 hours after the dose. b Amoxicillin/clavulanate potassium administered at the start of a light meal. Table 7: Mean (±S.D.) Amoxicillin and Clavulanate Potassium Pharmacokinetic Parameters a,b with Amoxicillin and Clavulanate Potassium Powder for Oral Suspension and Chewable Tablets Dose of AUGMENTIN C max (mcg/mL) AUC 0-24 (mcg*h/mL) Amoxicillin and Clavulanate potassium Amoxicillin Clavulanate potassium Amoxicillin Clavulanate potassium 400/57 mg(5 mL of suspension) 6.94 ± 1.24 1.10 ± 0.42 17.29 ± 2.28 2.34 ± 0.94 400/57 mg(1 chewable tablet) 6.67 ± 1.37 1.03 ± 0.33 17.24 ± 2.64 2.17 ± 0.73 a Mean (± standard deviation) values of 28 normal adults.

Peak concentrations occurred approximately 1 hour after the dose. b Amoxicillin/clavulanate potassium administered at the start of a light meal. Oral administration of 5 mL of the 250 mg/62.5 mg suspension of AUGMENTIN or the equivalent dose of 10 mL of the 125 mg/31.25 mg suspension of AUGMENTIN provides average peak serum concentrations approximately 1 hour after dosing of 6.9 mcg/mL for amoxicillin and 1.6 mcg/mL for clavulanic acid. The areas under the serum concentration curves obtained during the first 4 hours after dosing were 12.6 mcg*h/mL for amoxicillin and 2.9 mcg*h/mL for clavulanic acid when 5 mL of the 250 mg/62.5 mg suspension of AUGMENTIN or equivalent dose of 10 mL of the 125 mg/31.25 mg suspension of AUGMENTIN were administered to normal adults.

One 250 mg/62.5 mg chewable tablet of AUGMENTIN or two 125 mg/31.25 mg chewable tablets of AUGMENTIN are equivalent to 5 mL of the 250 mg/62.5 mg suspension of AUGMENTIN and provide similar serum concentrations of amoxicillin and clavulanic acid. Amoxicillin serum concentrations achieved with AUGMENTIN are similar to those produced by the oral administration of equivalent doses of amoxicillin alone. Time above the minimum inhibitory concentration of 1 mcg/mL for amoxicillin has been shown to be similar after corresponding every 12 hour and every 8-hour dosing regimens of AUGMENTIN in adults and children.

Absorption: Dosing in the fasted or fed state has minimal effect on the pharmacokinetics of amoxicillin. While AUGMENTIN can be given without regard to meals, absorption of clavulanate potassium when taken with food is greater relative to the fasted state. In one study, the relative bioavailability of clavulanate was reduced when AUGMENTIN was dosed at 30 and 150 minutes after the start of a high-fat breakfast.

Distribution: Neither component in AUGMENTIN is highly protein-bound; clavulanic acid is approximately 25% bound to human serum and amoxicillin approximately 18% bound. Amoxicillin diffuses readily into most body tissues and fluids with the exception of the brain and spinal fluid. Two hours after oral administration of a single 35 mg/kg dose of suspension of AUGMENTIN to fasting children, average concentrations of 3 mcg/mL of amoxicillin and 0.5 mcg/mL of clavulanic acid were detected in middl… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Lower Respiratory Tract and Complicated Urinary Tract Infections Data from 2 pivotal trials in 1,191 patients treated for either lower respiratory tract infections or complicated urinary tract infections compared a regimen of 875 mg/125 mg tablets of AUGMENTIN every 12 hours to 500 mg/125 mg tablets of AUGMENTIN dosed every 8 hours (584 and 607 patients, respectively). Comparable efficacy was demonstrated between the every 12 hours and every 8 hours dosing regimens. There was no significant difference in the percentage of adverse events in each group.

The most frequently reported adverse event was diarrhea; incidence rates were similar for the 875 mg every 12 hours and 500 mg every 8 hours dosing regimens (15% and 14%, respectively); however, there was a statistically significant difference (p less than 0.05) in rates of severe diarrhea or withdrawals with diarrhea between the regimens: 1% for 875 mg every 12 hours regimen versus 2% for the 500 mg every 8 hours regimen. In one of these pivotal trials, patients with either pyelonephritis (n equals 361) or a complicated urinary tract infection (i.e., patients with abnormalities of the urinary tract that predispose to relapse of bacteriuria following eradication, n equals 268) were randomized (1:1) to receive either 875 mg/125 mg tablets of AUGMENTIN every 12 hours (n equals 308) or 500 mg/125 mg tablets of AUGMENTIN every 8 hours (n equals 321).

The number of bacteriologically evaluable patients was comparable between the two dosing regimens. AUGMENTIN produced comparable bacteriological success rates in patients assessed 2 to 4 days immediately following end of therapy. The bacteriologic efficacy rates were comparable at one of the follow-up visits (5 to 9 days post-therapy) and at a late post-therapy visit (in the majority of cases, this was 2 to 4 weeks post-therapy), as seen in Table 8.

Table 8: Bacteriologic efficacy rates for AUGMENTIN Time Post Therapy 875 mg every 12 hours % (n) 500 mg every 8 hours % (n) 2 to 4 days 81% (58) 80% (54) 5 to 9 days 58% (41) 52% (52) 2 to 4 weeks 52% (101) 55% (104) As noted, before, though there was no significant difference in the percentage of adverse events in each group, there was a statistically significant difference in rates of severe diarrhea or withdrawals with diarrhea between the regimens.

14.2Acute Bacterial Otitis Media and Diarrhea in Pediatric Patients One US/Canadian clinical trial was conducted which compared 45/6.4 mg/kg/day (divided every 12 hours) of AUGMENTIN for 10 days versus 40/10 mg/kg/day (divided every 8 hours) of AUGMENTIN for 10 days in the treatment of acute otitis media. Only the suspension formulations were used in this trial. A total of 575 pediatric patients (aged 2 months to 12 years) were enrolled, with an even distribution among the 2 treatment groups and a comparable number of patients were evaluable (i.e., greater than or equal to 84%) per treatment group.

Otitis media-specific criteria were required for eligibility and a strong correlation was found at the end of therapy and follow-up between these criteria and physician assessment of clinical response. The clinical efficacy rates at the end of therapy visit (defined as 2 to 4 days after the completion of therapy) and at the follow-up visit (defined as 22 to 28 days post-completion of therapy) were comparable for the 2 treatment groups, with the following cure rates obtained for the evaluable patients: At end of therapy, 87% (n equals 265) and 82% (n equals 260) for 45 mg/kg/day every 12 hours and 40 mg/kg/day every 8 hours, respectively.

At follow-up, 67% (n equals 249) and 69% (n equals 243) for 45 mg/kg/day every 12 hours and 40 mg/kg/day every 8 hours, respectively. Diarrhea was defined as either: (a) 3 or more watery or 4 or more loose/watery stools in 1 day; OR (b) 2 watery stools per day or 3 loose/watery stools per day for 2 consecutive days. The incidence of diarrhea was significantly lower in patients who received… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 193 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment Of Fertility Long-term studies in animals have not been performed to evaluate carcinogenic potential. AUGMENTIN (4:1 ratio formulation of amoxicillin:clavulanate) was non-mutagenic in the Ames bacterial mutation assay, and the yeast gene conversion assay. AUGMENTIN was weakly positive in the mouse lymphoma assay, but the trend toward increased mutation frequencies in this assay occurred at doses that were also associated with decreased cell survival.

AUGMENTIN was negative in the mouse micronucleus test, and in the dominant lethal assay in mice. Potassium clavulanate alone was tested in the Ames bacterial mutation assay and in the mouse micronucleus test and was negative in each of these assays. AUGMENTIN (2:1 ratio formulation of amoxicillin:clavulanate) at oral doses of up to 1,200 mg/kg/day was found to have no effect on fertility and reproductive performance in rats.

Based on body surface area, this dose of amoxicillin is approximately 4 times the maximum recommended adult human oral dose (875 mg every 12 hours). For clavulanate, the dose multiple is approximately 9 times higher than the maximum recommended adult human oral dose (125 mg every 8 hours), also based on body surface area.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 190 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment Of Fertility Long-term studies in animals have not been performed to evaluate carcinogenic potential. AUGMENTIN (4:1 ratio formulation of amoxicillin:clavulanate) was non-mutagenic in the Ames bacterial mutation assay, and the yeast gene conversion assay. AUGMENTIN was weakly positive in the mouse lymphoma assay, but the trend toward increased mutation frequencies in this assay occurred at doses that were also associated with decreased cell survival.

AUGMENTIN was negative in the mouse micronucleus test, and in the dominant lethal assay in mice. Potassium clavulanate alone was tested in the Ames bacterial mutation assay and in the mouse micronucleus test and was negative in each of these assays. AUGMENTIN (2:1 ratio formulation of amoxicillin:clavulanate) at oral doses of up to 1,200 mg/kg/day was found to have no effect on fertility and reproductive performance in rats.

Based on body surface area, this dose of amoxicillin is approximately 4 times the maximum recommended adult human oral dose (875 mg every 12 hours). For clavulanate, the dose multiple is approximately 9 times higher than the maximum recommended adult human oral dose (125 mg every 8 hours), also based on body surface area.

📚 References 31 words ▾

15 REFERENCES 1. Swanson-Biearman B, Dean BS, Lopez G, Krenzelok EP. The effects of penicillin and cephalosporin ingestions in children less than six years of age.Vet Hum Toxicol. 1988; 30: 66‑67.

📄 Package Label / Principal Display Panel 52 words ▾

PRINCIPAL DISPLAY PANEL NDC 73043- 010 -03 Amoxicillin and Clavulanate Potassium for Oral Suspension, USP 250 mg/62.5 mg per 5 mL When reconstituted, each 5 mL contains: AMOXICILLIN, 250 MG, as the trihydrate and CLAVULANIC ACID,

62.5MG (equivalent to 74.5 mg of clavulanate potassium) Rx only 150mL (when reconstituted) Devatis Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
826
Units reimbursed last 4 qtrs
78.9K
Gross reimbursed last 4 qtrs
$48.6K
Avg / prescription
$58.80
Avg / unit
$0.6154
Latest quarter Q1 2026
352Rx
Medicaid pays / mL
$0.6154
gross reimbursed
vs
NADAC / mL
$0.4354
acquisition cost
=
Spread
+$0.1800
+41% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
12% FFS 88% MCO
Fee-for-service · 99 Rx Managed care · 727 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 1,600 units · 15.9 per 100k residents MI New York: 6,075 units · 31.0 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 7,225 units · 18.5 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 10,425 units · 228 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
15.9228
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Louisiana 228 /100k
2 New York 31.0 /100k
3 California 18.5 /100k
4 Michigan 15.9 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 ml73043-0010-02 1,277 Rx · $97,949
150 ml73043-0010-03 1,101 Rx · $130,936
75 ml this page73043-0010-01 826 Rx · $48,572
Drug total (last 4 qtrs): 3,204 Rx · 533,762 units · $277,457 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
← 73043-0009-01 · Devatis, 73043-0011-05 · Devatis, →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.