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AMOXICILLIN AND CLAVULANATE POTASSIUM 875 mg; 125 mg Tablet, Film Coated, 90-count

by Proficient Rx LP · 90 TABLET, FILM COATED in 1 BOTTLE (71205-331-90)
NDC 71205-0331-90
🏷️ FDA NDC (as labeled) 71205-331-90 billing pads the product segment with a zero
This package
Contains90-count Pack sizes6 compare ↓
Also priced by: Part D plans $0.0932/unit — full pricing hub ↓
Also comes in: 14 tablets 71205-0331-14 15 tablets 71205-0331-15 20 tablets 71205-0331-20 30 tablets 71205-0331-30 60 tablets 71205-0331-60
Rx only Generic On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 71205-331-90
Product NDC 71205-331
11-digit billing NDC 71205033190
RxCUI 562508
UNII 804826J2HU, Q42OMW3AT8
UPC 0371205331146
Application # ANDA204755
SPL Set ID e08c1bee-14c8-4bd1-898c-1874251dadf8
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 2017-03-01
Route ORAL
Dosage form TABLET, FILM COATED
Substance AMOXICILLIN; CLAVULANATE POTASSIUM
GCN Seq No 024668
GCN 67076
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 875-125 MG TABLET
FDB brand name Amoxicillin-Clavulanate Potass
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 71205-331-90 — 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 → 71205-0331-90. 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.

🏭 Manufacturer & labeler

LabelerProficient Rx LP
Application holderMICRO LABS LTD INDIA
FDA applicationANDA204755 (ANDA)
Labeler code71205
First marketedMar 2017
Product typeHuman Prescription Drug
Portfolio1,723 products on file
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.

🩺 Clinical

Label name AMOX-CLAV 875-125 MG TABLET 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
  • This antibiotic is used for a range of common bacterial infections — ear infections, sinus infections, lower respiratory tract infections, skin infections, and urinary tract infect...
  • What infections does amoxicillin/clavulanate actually treat?
  • Taking it at the start of a meal is the best approach. Food doesn't affect amoxicillin much, but it does meaningfully improve how much clavulanate your body absorbs. More important...
  • Should I take this with food or on an empty stomach?
📖 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.

💊 What it looks like

Color white
ShapeCapsule
ImprintI07
Size22 mm
ScoringScored — splits in 2
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.

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

  • UNII 3DYK7UYZ62
    Ethylcellulose is a plant-fiber derivative used as a binder and film-coating agent in tablets and capsules. It helps hold ingredients together and can create a protective coating that controls how quickly the medicine dissolves.
  • UNII R75537T0T4
    Hypromellose 2910 is a plant-derived thickening agent made from cellulose. It serves as a binder that holds tablet ingredients together, a film-coating for pills, and a viscosity controller in liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • 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 B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • 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 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

9 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.

💲 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.0932 $8.39 / 90 tablets
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 00093-2275-34 Teva 20 tablets $0.286 AB Availability likely —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 00143-9249-20 Hikma 20 tablets $0.286 AB Availability likely —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 00781-1852-01 Sandoz 100 tablets $0.286 AB Availability likely —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 16714-0297-01 NorthStar 20 tablets $0.286 AB Availability likely —
Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mg 42571-0162-01 Micro 100 tablets $0.286 AB Availability likely —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 60687-0803-01 American 1 tablet $0.286 AB Availability likely —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 65862-0503-01 Aurobindo 100 tablets $0.286 AB Availability likely —
Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mg 81964-0221-14 USAntibiotics, 20 tablets $0.286 AB Availability likely —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 16714-0014-01 Northstar 20 tablets $0.340 AB Discontinued —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 43063-0077-03 PD-Rx 3 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 43063-0377-02 PD-Rx 2 tablets — AB FDA listed —
Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mg 45865-0227-20 Medsource 20 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 50090-0822-00 A-S 20 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 50090-1809-00 A-S 20 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 50090-3179-00 A-S 20 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 50090-4413-00 A-S 20 tablets — AB FDA listed —
Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mg 50090-6324-00 A-S 20 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 50090-7003-00 A-S 14 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 50090-7415-00 A-S 14 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 55289-0767-10 PD-Rx 10 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 63187-0014-14 Proficient 14 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 63187-0327-20 Proficient 20 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 63187-0488-14 Proficient 14 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 63629-4541-01 Bryant 14 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 63629-5847-01 Bryant 6 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 67046-0955-03 Coupler 30 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 68071-2982-02 NuCare 20 tablets — AB FDA listed —
Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mg 68071-3402-03 NuCare 30 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 68071-3822-03 NuCare 3 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 68071-3842-02 NuCare 20 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 68071-3860-02 NuCare 20 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 68071-3864-04 NuCare 14 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 68071-3866-03 NuCare 30 tablets — AB FDA listed —
Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mg 68071-4224-02 NuCare 20 tablets — AB FDA listed —
Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mg 68071-4549-03 NuCare 3 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 68071-4586-03 NuCare 30 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 68071-4967-02 NuCare 20 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 68071-5026-04 NuCare 14 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 68071-5057-03 NuCare 3 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 68071-5065-03 NuCare 3 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 68071-5295-03 NuCare 3 tablets — AB FDA listed —
Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mg 68788-7531-02 Preferred 20 tablets — AB FDA listed —
Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mg 68788-8307-02 Preferred 20 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 68788-8836-02 Preferred 20 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 70518-2225-00 REMEDYREPACK 20 tablets — AB FDA listed —
Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mg 70518-2263-03 REMEDYREPACK 1 tablet — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 70518-3604-00 REMEDYREPACK 1 tablet — AB Discontinued —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 70518-3624-00 REMEDYREPACK 1 tablet — AB Discontinued —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 70518-3676-00 REMEDYREPACK 1 tablet — AB Discontinued —
Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mg 70518-3967-00 REMEDYREPACK 28 tablets — AB Discontinued —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 70518-4148-00 REMEDYREPACK 100 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 70518-4424-00 REMEDYREPACK 30 tablets — AB FDA listed —
Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mgthis 71205-0331-90 Proficient 90 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 71205-0651-10 Proficient 10 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 71205-0712-10 Proficient 10 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 71335-2787-01 Bryant 10 tablets — AB FDA listed —
Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mg 71335-2917-01 Bryant 100 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 71335-3138-01 Bryant 20 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 72162-2211-02 Bryant 20 tablets — AB FDA listed —
Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mg 72162-2434-01 Bryant 100 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 72789-0147-03 PD-Rx 3 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 72789-0253-20 PD-Rx 20 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 72789-0421-14 PD-Rx 14 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 72789-0456-14 PD-Rx 14 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 72789-0459-14 PD-Rx 14 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 73043-0006-20 Devatis, 20 tablets — AB FDA listed —
Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mg 76420-0005-20 Asclemed 20 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 76420-0501-20 Asclemed 20 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 76420-0529-20 Asclemed 20 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 76420-0607-01 Asclemed 100 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 125 mg/1; 875 mg 80425-0180-01 Advanced 20 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 80425-0279-01 Advanced 20 tablets — AB FDA listed —
Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mg 81964-0575-83 USAntibiotics, 180 tablets — AB FDA listed —
Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mg 82804-0060-20 Proficient 20 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 82804-0177-14 Proficient 14 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 82804-0201-20 Proficient 20 tablets — AB FDA listed —
Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mg 82868-0002-10 Northwind 10 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 82868-0067-14 Northwind 14 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 85766-0019-01 Sportpharm 100 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 85766-0078-01 Sportpharm 100 tablets — AB FDA listed —
Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mg 85766-0171-14 Sportpharm 14 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 68071-2751-02 NuCare 20 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 68788-4158-02 Preferred 20 tablets — AB FDA listed —
amoxicillin and clavulanate potassium 875 mg/1; 125 mg 62135-0092-20 Chartwell 20 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 72789-0585-28 PD-Rx 28 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 85766-0268-01 Sportpharm 1 tablet — AB FDA listed —
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

🏛️
2017
On the market since
Mar 2017
📍
2026
Currently FDA-listed
9 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Amoxicillin and clavulanate potassium — the ingredient across all brands.

Top reported reactions

Diarrhoea1,880
Drug Hypersensitivity1,818
Nausea1,435
Dyspnoea1,404
Pyrexia1,399
Fatigue1,280
Pneumonia1,191

Age at onset

Neonate22
Infant18
Child89
Adolescent65
Adult1,981
Elderly1,579

Reporter sex

27,021 reports
Male · 43%
Female · 57%
Unknown · 0%

Serious outcomes

Hospitalization13,276
Death2,605
Life-threatening1,837
Disabling591
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 2,029 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
71205-0331-14 14 TABLET, FILM COATED in 1 BOTTLE (71205-331-14) 2020-05-05 Active
71205-0331-15 15 TABLET, FILM COATED in 1 BOTTLE (71205-331-15) 2019-10-01 Active
71205-0331-20 20 TABLET, FILM COATED in 1 BOTTLE (71205-331-20) 2019-10-01 Active
71205-0331-30 30 TABLET, FILM COATED in 1 BOTTLE (71205-331-30) 2019-10-01 Active
71205-0331-60 60 TABLET, FILM COATED in 1 BOTTLE (71205-331-60) 2019-10-01 Active
71205-0331-90 You're viewing this 90 TABLET, FILM COATED in 1 BOTTLE (71205-331-90) 2019-10-01 Active

You're viewing the largest of 6 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 71205-0331-90?
NDC 71205-0331-90 is a 90-count package — 90 tablet, film coated in 1 bottle.
What is the difference between NDC 71205-0331-90 and NDC 71205-0331-14?
Both are AMOXICILLIN AND CLAVULANATE POTASSIUM 875 mg; 125 mg Tablet, Film Coated — the drug itself is identical. NDC 71205-0331-90 is the 90-count package, while NDC 71205-0331-14 is the 14 tablets package.
What NDC number is used to bill for this package of AMOXICILLIN AND CLAVULANATE POTASSIUM 875 mg; 125 mg Tablet, Film Coated?
Bill NDC 71205-0331-90 — the 11-digit billing format is 71205033190. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 71205-331-90, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 71205-0331-90, written without dashes as 71205033190. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 71205-0331-90, the first segment (71205) is the labeler code FDA assigned to Proficient Rx LP; the middle segment (0331) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (90) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Proficient Rx LP. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 5 other package presentations of this same product, including 14 tablets (71205-0331-14), 15 tablets (71205-0331-15), 20 tablets (71205-0331-20). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
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📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. 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 💬 Information for Patients
🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets USP, and other antibacterial drugs, amoxicillin and clavulanate potassium should be used only to treat 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 tablets USP is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*: Amoxicillin and clavulanate potassium tablets USP are combination penicillin-class antibacterial and beta-lactamase inhibitor indicated for treatment of the following: Lower respiratory tract infections ( 1.1 ) Acute bacterial otitis media ( 1.2 ) Sinusitis ( 1.3 ) Skin and skin structure infections ( 1.4 ) Urinary tract infections ( 1.5 )

1.1Lower Respiratory Tract Infections – caused by beta-lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis .

1.2Acute Bacterial Otitis Media – caused by beta-lactamase–producing isolates of H. influenzae and M. catarrhalis .

1.3Sinusitis – caused by beta-lactamase–producing isolates of H. influenzae and M. catarrhalis .

1.4Skin and Skin Structure Infections – caused by beta-lactamase–producing isolates of Staphylococcus aureus , Escherichia coli , and Klebsiella species.

1.5Urinary Tract Infections – caused by beta-lactamase–producing isolates of E. coli , Klebsiella species, and Enterobacter species.

1.6Limitations of Use – When susceptibility test results show susceptibility to amoxicillin, USP, indicating no beta-lactamase production, amoxicillin and clavulanate potassium tablets USP should not be used.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Amoxicillin and clavulanate potassium may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium should be taken at the start of a meal. • Adults and Pediatric Patients > 40 kg: 500 mg/125 mg or 875 mg/125 mg every 12 hours or 250 mg/125 mg or 500 mg/125 mg every 8 hours. ( 2.1 , 2.2 ) • 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.

( 2.2 )

2.1Adults The usual adult dose is one 500 mg/125 mg amoxicillin and clavulanate potassium tablet every 12 hours or one 250 mg/125 mg amoxicillin and clavulanate potassium tablet every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875 mg/125 mg amoxicillin and clavulanate potassium tablet every 12 hours or one 500 mg/125 mg amoxicillin and clavulanate potassium tablet every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet.

The 200 mg/28.5 mg per 5 mL suspension or the 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet. Two 250 mg/125 mg amoxicillin and clavulanate potassium tablets should not be substituted for one 500 mg/125 mg amoxicillin and clavulanate potassium tablet. Since both the 250 mg/125 mg and 500 mg/125 mg amoxicillin and clavulanate potassium tablets contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg tablets are not equivalent to one 500 mg/125 mg amoxicillin and clavulanate potassium tablet.

The 250 mg/125 mg amoxicillin and clavulanate potassium tablet and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250 mg/125 mg amoxicillin and clavulanate potassium tablet and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250 mg/125 mg amoxicillin and clavulanate potassium tablet contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid.

2.2Pediatric Patients Based on the amoxicillin component, amoxicillin and clavulanate potassium should be dosed as follows: Neonates and Infants Aged <12 weeks (<3 months): The recommended dose of amoxicillin and clavulanate potassium tablet is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/5 mL formulation in this age group is limited, and thus, use of the 125 mg/5 mL oral suspension is recommended. Patients Aged 12 weeks (3 months) and Older: See dosing regimens provided in Table 1.

The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies ( 14.2 )] . Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older INFECTION DOSING REGIMEN Every 12 hours Every 12 hours 200 mg/5 mL or 400 mg/5 mL oral suspension a 125 mg/5 mL or 250 mg/5 mL oral suspension a Otitis media b , sinusitis, lower respiratory tract infections, and more severe infections 45 mg/kg/day every 12 hours 40 mg/kg/day every 8 hours Less severe infections 25 mg/kg/day every 12 hours 20 mg/kg/day every 8 hours a Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children. b Duration of therapy studied and recommended for acute otitis media is 10 days.

Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations. The 250 mg/125 mg amoxicillin and clavulanate potassium tablets should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic…

💊 Dosage Forms and Strengths ~1 min read ▾

3 DOSAGE FORMS AND STRENGTHS 250 mg/125 mg Tablets: White to off-white colored, capsule shaped, biconvex, film-coated tablets, debossed with “I 05” on one side and plain on the other side. Each tablet contains 250 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. 500 mg/125 mg Tablets: White to off-white colored, capsule shaped, biconvex, film-coated tablets debossed with “I 06” on one side and plain on the other side.

Each tablet contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. 875 mg/125 mg Tablets: white to off-white colored, capsule shaped, biconvex, film-coated tablets debossed with “I 07” on one side score line on the other side. Each tablet contains 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt.

The 250 mg/125 mg amoxicillin and clavulanate potassium tablet and the 250 mg/62.5 mg chewable tablet should NOT be substituted for each other, as they are not interchangeable and the 250 mg/125 mg tablet should not be used in children weighing less than 40 kg. The 250 mg/125 mg amoxicillin and clavulanate potassium tablet and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid. The 250 mg/125 mg amoxicillin and clavulanate potassium tablet contains 125 mg of clavulanic acid whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid.

Two 250 mg/125 mg amoxicillin and clavulanate potassium tablets should NOT be substituted for one 500 mg/125 mg amoxicillin and clavulanate potassium tablet. Since both the 250 mg/125 mg and 500 mg/125 mg amoxicillin and clavulanate potassium tablets contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg amoxicillin and clavulanate potassium tablets are not equivalent to one 500 mg/125 mg amoxicillin and clavulanate potassium tablet. Tablets: 250 mg/125 mg, 500 mg/125 mg and 875 mg/125 mg ( 3 )

⛔ Contraindications 108 words ▾

4 CONTRAINDICATIONS • History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin and clavulanate potassium or to other beta-lactams (e.g., penicillins or cephalosporins) ( 4 ) • History of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium. ( 4 )

4.1Serious Hypersensitivity Reactions Amoxicillin and clavulanate potassium 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 is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium.

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS • Serious (including fatal) hypersensitivity reactions: Discontinue amoxicillin and clavulanate potassium if a reaction occurs. ( 5.1 ) • Hepatic dysfunction and cholestatic jaundice: Discontinue if signs/symptoms of hepatitis occur. Monitor liver function tests in patients with hepatic impairment.

( 5.2 ) • Clostridium difficile -associated diarrhea (CDAD): Evaluate patients if diarrhea occurs. ( 5.3 ) • Patients with mononucleosis who receive amoxicillin and clavulanate potassium develop skin rash. Avoid amoxicillin and clavulanate potassium use in these patients.

( 5.4 ) • Overgrowth: The possibility of superinfections with fungal or bacterial pathogens should be considered during therapy. ( 5.5 )

5.1Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterials, including amoxicillin and clavulanate potassium. 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, careful inquiry should be made regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens.

If an allergic reaction occurs, amoxicillin and clavulanate potassium tablets should be discontinued and appropriate therapy instituted.

5.2Hepatic Dysfunction Hepatic dysfunction, including hepatitis and cholestatic jaundice has been associated with the use of amoxicillin and clavulanate potassium. Hepatic toxicity is usually reversible; however, deaths have been reported. Hepatic function should be monitored at regular intervals in patients with hepatic impairment.

5.3Clostridium difficile-Associated Diarrhea (CDAD) Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including amoxicillin and clavulanate potassium, 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 the development of CDAD.

Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.

5.4Skin Rash in Patients with Mononucleosis A high percentage of patients with mononucleosis who receive amoxicillin develop an erythematous skin rash. Thus, amoxicillin and clavulanate potassium tablets should not be administered to patients with mononucleosis.

5.5Potential for Microbial Overgrowth The possibility of superinfections with fungal or bacterial pathogens should be considered during therapy. If superinfection occurs, amoxicillin and clavulanate potassium should be discontinued and appropriate therapy instituted.

5.7Development of Drug-Resistant Bacteria Prescribing amoxicillin and clavulanate potassium tablets in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient, and increases the risk of the development of drug-resistant bacteria.

🤒 Adverse Reactions ~2 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) ] • Hepatic Dysfunction [see Warnings and Precautions (5.2) ] • CDAD [see Warnings and Precautions (5.3) ] 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 Micro Labs USA, Inc. at 1-855-839-8195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials 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 (<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 amoxicillin and clavulanate potassium for 10 days versus 40/10 mg/kg/day (divided every 8 hours) of amoxicillin and clavulanate potassium 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 amoxicillin and clavulanate potassium. 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 amoxicillin and clavulanate potassium.

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 antibiotic treatment. [see Warnings and Precautions (5.3) ] Hypersensitivity Reactions: Pruritus, angioedema, serum sickness–like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), erythema multiforme, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, hypersensitivity vasculitis, and cases of exfoliative dermatitis (including toxic epidermal necrolysis) have been reported. [see Warnings and Precautions (5.1) ] 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 amoxicillin and clavulanate potassium.

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 Precautions (5.2) ] Renal: Interstitial nephritis…

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS • Co-administration with probenecid is not recommended. ( 7.1 ) • Concomitant use of amoxicillin and clavulanate potassium 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 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. Coadministration 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 (GFR< 30 mL/min). ( 2.3 , 8.6 )

8.1Pregnancy Teratogenic Effects Pregnancy Category B Reproduction studies performed in pregnant rats and mice given amoxicillin and clavulanate potassium (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 amoxicillin and clavulanate potassium. 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/125 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 antibiotics 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 amoxicillin and clavulanate potassium for oral suspension and chewable tablets have been established in pediatric patients. Use of amoxicillin and clavulanate potassium in pediatric patients is supported by evidence from studies of amoxicillin and clavulanate potassium tablets in adults with additional data from a study of amoxicillin and clavulanate potassium 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 <12 weeks (<3 months). [ see Dosage and Administration (2.2) ]

8.5Geriatric Use Of the 3,119 patients in an analysis of clinical studies of amoxicillin and clavulanate potassium, 32% were ≥65 years old, and 14% were ≥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.

8.6Dosing in Renal Impairment Amoxicillin is primarily eliminated by the kidney and dosage adjustment is usually required in patients with severe renal impairment (GFR < 30 mL/min). See Patients with Renal Impairment (2.3) for specific recommendations in patients with renal impairment.

🤰 Pregnancy 133 words ▾

8.1Pregnancy Teratogenic Effects Pregnancy Category B Reproduction studies performed in pregnant rats and mice given amoxicillin and clavulanate potassium (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 amoxicillin and clavulanate potassium. 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/125 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 129 words ▾

8.4Pediatric Use The safety and effectiveness of amoxicillin and clavulanate potassium for oral suspension and chewable tablets have been established in pediatric patients. Use of amoxicillin and clavulanate potassium in pediatric patients is supported by evidence from studies of amoxicillin and clavulanate potassium tablets in adults with additional data from a study of amoxicillin and clavulanate potassium 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 <12 weeks (<3 months). [ see Dosage and Administration (2.2) ]

🧓 Geriatric Use 128 words ▾

8.5Geriatric Use Of the 3,119 patients in an analysis of clinical studies of amoxicillin and clavulanate potassium, 32% were ≥65 years old, and 14% were ≥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 161 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 symptoms 1 . 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 (2.3) ]

🧬 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 amoxicillin and clavulanate potassium tablets are shown in Table 3 and following administration of amoxicillin and clavulanate potassium for oral suspension and chewable tablets are shown in Table 4 . Table 3: Mean (±S.D.) Amoxicillin and Clavulanate Potassium Pharmacokinetic Parameters ab With Amoxicillin and Clavulanate Potassium Tablets Dose and Regimen C max (mcg/mL) AUC 0 to 24 (mcg*h/mL) Amoxicillin and Clavulanate Potassium Amoxicillin Clavulanate Potassium Amoxicillin Clavulanate Potassium 250 mg/125 mg every 8 hours 3.3 ± 1.12 1.5 ± 0.70 26.7 ± 4.56 12.6 ± 3.25 500 mg/125 mg every 12 hours 6.5 ± 1.41 1.8 ± 0.61 33.4 ± 6.76 8.6 ± 1.95 500 mg/125 mg every 8 hours 7.2 ± 2.26 2.4 ± 0.83 53.4 ± 8.87 15.7 ± 3.86 875 mg/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 and clavulanate potassium administered at the start of a light meal. Table 4: Mean (±S.D.) Amoxicillin and Clavulanate Potassium Pharmacokinetic Parameters a,b with Amoxicillin and Clavulanate Potassium Powder for Oral Suspension and Chewable Tablets Dose C max (mcg/mL) AUC 0 to 24 (mcg*h/mL) Amoxicillin/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 250 mg/62.5 mg per 5 mL suspension of amoxicillin and clavulanate potassium or the equivalent dose of 10 mL of 125 mg/31.5 mg per 5 mL suspension of amoxicillin and clavulanate potassium 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 250 mg/5 mL suspension of amoxicillin and clavulanate potassium or equivalent dose of 10 mL of 125 mg/5 mL suspension of amoxicillin and clavulanate potassium were administered to normal adults.

One 250 mg/62.5 mg chewable tablet of amoxicillin and clavulanate potassium or two 125 mg/31.25 mg chewable tablet of amoxicillin and clavulanate potassium are equivalent to 5 mL of 250 mg/5 mL suspension of amoxicillin and clavulanate potassium and provide similar serum concentrations of amoxicillin and clavulanic acid. Amoxicillin serum concentrations achieved with amoxicillin and clavulanate potassium 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 amoxicillin and clavulanate potassium in adults and children.

Absorption: Dosing in the fasted or fed state has minimal effect on the pharmacokinetics of amoxicillin. While amoxicillin and clavulanate potassium 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 amoxicillin and clavulanate potassium was dosed at 30 and 150 minutes after the start of a high-fat breakfast.

Distribution: N…

🧬 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 130 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Amoxicillin and Clavulanate Potassium Tablets USP are supplied as follows: Amoxicillin and clavulanate potassium tablets USP, 875 mg/125 mg are white to off-white colored, capsule shaped, biconvex, film-coated tablets debossed with “I 07” on one side score line on the other side. Each tablet contains 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. They are available as follows.

Bottles of 14 NDC 71205-331-14 Bottles of 15 NDC 71205-331-15 Bottles of 20 NDC 71205-331-20 Bottles of 30 NDC 71205-331-30 Bottles of 60 NDC 71205-331-60 Bottles of 90 NDC 71205-331-90 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tightly closed, moisture-proof containers. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

📋 Description ~1 min read ▾

11 DESCRIPTION Amoxicillin and clavulanate potassium tablets, USP is an oral antibacterial combination consisting of amoxicillin and the β-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin, USP is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. Chemically, amoxicillin, USP is ( 2S , 5R , 6R )-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: C 16 H 19 N 3 O 5 S•3H 2 O M.W.

419.45 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, USP is potassium ( Z )-(2 R ,5 R )-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate, and may be represented structurally as: C 8 H 8 KNO 5 M.W. 237.25 Each tablet contains 250 mg, 500 mg or 875 mg amoxicillin, USP as the trihydrate and 125 mg clavulanic acid as the potassium salt. Each Amoxicillin and Clavulanate Potassium Tablet USP contains 0.63 mEq potassium.

Inactive Ingredients: colloidal silicon dioxide, ethylcellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide. Meets USP Dissolution Test 1 amoxicillin structure clavulanate potassium structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION

17.1Information for Patients Patients should be informed that amoxicillin and clavulanate potassium tablets may be taken every 8 hours or every 12 hours, depending on the dose prescribed. Each dose should be taken with a meal or snack to reduce the possibility of gastrointestinal upset. Patients should be counseled that antibacterial drugs, including amoxicillin and clavulanate potassium tablets, should only be used to treat bacterial infections.

They do not treat viral infections (e.g., the common cold). When amoxicillin and clavulanate potassium tablets are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by amoxicillin and clavulanate potassium tablets or other antibacterial drugs in the future.

Counsel patients that diarrhea is a common problem caused by antibacterials, and it usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken their last dose of the antibacterial. If diarrhea is severe or lasts more than 2 or 3 days, patients should contact their physician.

Patients should be advised to keep suspension refrigerated. Shake well before using. When dosing a child with the suspension (liquid) of amoxicillin and clavulanate potassium, use a dosing spoon or medicine dropper.

Be sure to rinse the spoon or dropper after each use. Bottles of suspension of amoxicillin and clavulanate potassium may contain more liquid than required. Follow your doctor’s instructions about the amount to use and the days of treatment your child requires.

Discard any unused medicine. Patients should be aware that amoxicillin and clavulanate potassium tablets contain a penicillin class drug product that can cause allergic reactions in some individuals. All brand names listed are the registered trademarks of their respective owners and are not trademarks of Micro Labs Limited.

Manufactured by: Micro Labs Limited Banglore-560 100, India. Manufactured for: Micro Labs USA Inc. Basking Ridge, NJ 07920 Packaged by: RedPharm Drug Inc Eden Prairie, MN 55344 Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 Revised: September 2018

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