Home › NDC Lookup › Ingredients › Amoxicillin And Clavulanate Potassium › 42571-0395-77

🧴image loading
(from DailyMed)

Amoxicillin and clavulanate potassium 600 mg/5mL; 42.9 mg/5mL For Suspension, 200 mL

by Micro Labs Limited · 200 mL in 1 BOTTLE (42571-395-77)

NDC 42571-0395-77

🏷️ FDA NDC (as labeled) 42571-395-77 billing pads the product segment with a zero

This package

Contains200 mL Pack sizes3 compare ↓

Also priced by: Part D plans $0.1176/unit — full pricing hub ↓

Also comes in: 75 ml 42571-0395-46 125 ml 42571-0395-70

Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm

🗂️ 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 Dr. Brian Staiger, PharmD

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

⚠️

Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Aug 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 42571-395-77

Product NDC 42571-395

11-digit billing NDC 42571039577

RxCUI 617993

UNII 804826J2HU, Q42OMW3AT8

UPC 0342571395469

Application # ANDA217805

SPL Set ID 26992a71-e4a0-4e41-aa3c-3219868c2226

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 Discontinued

FDA listing status Discontinued by firm (certified through Aug 2026)

Marketing start 2024-04-01

Route ORAL

Dosage form FOR SUSPENSION

Substance AMOXICILLIN; CLAVULANATE POTASSIUM

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 42571-395-77 — 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 → 42571-0395-77. 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

LabelerMicro Labs Limited

Application holderMICRO LABS LTD

FDA applicationANDA217805 (ANDA)

Labeler code42571

First marketedApr 2024

Product typeHuman Prescription Drug

Portfolio190 products on file

🔎 All NDCs from Micro Labs Limited

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

📗 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 →

Patient education

📘 MedlinePlus patient leaflet ↗

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.

🧪 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.

Where does this data come from?

Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 system	Per mL	Per 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	$0.1176	$23.52 / 200 ml

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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 00143-9853-16	Hikma	125 ml	$0.059	AB	Availability likely	—
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 00093-8675-74	Teva	200 ml	$0.061	AB	Availability likely	—
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 00781-6139-48	Sandoz	200 ml	$0.061	AB	Availability likely	—
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 65862-0535-02	Aurobindo	200 ml	$0.061	AB	Availability likely	—
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 16714-0294-01	NorthStar	75 ml	$0.071	AB	Availability likely	—
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 73043-0008-01	Devatis	75 ml	$0.071	AB	Availability likely	—
Amoxicillin And Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 81964-0203-51	USAntibiotics,	75 ml	$0.071	AB	Availability likely	—
Amoxicillin and clavulanate potassium 600 mg/5mL; 42.9 mg/5mLthis 42571-0395-77	Micro	200 ml	—	AB	Discontinued	—
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 50090-1857-00	A-S	125 ml	—	AB	FDA listed	—
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 50090-2219-00	A-S	125 ml	—	AB	FDA listed	—
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 63187-0857-12	Proficient	125 ml	—	AB	FDA listed	—
Amoxicillin And Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 67296-1921-07	Redpharm	75 ml	—	AB	FDA listed	—
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 67296-2234-01	Redpharm	75 ml	—	AB	FDA listed	—
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 68071-2355-05	NuCare	75 ml	—	AB	FDA listed	—
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 68071-2852-05	NuCare	125 ml	—	AB	FDA listed	—
Amoxicillin And Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 68071-3774-05	NuCare	125 ml	—	AB	FDA listed	—
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 68071-5144-05	NuCare	75 ml	—	AB	FDA listed	—
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 68071-5207-05	NuCare	125 ml	—	AB	FDA listed	—
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 68788-0483-01	Preferred	125 ml	—	AB	FDA listed	—
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 68788-8157-01	Preferred	125 ml	—	AB	FDA listed	—
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 68788-8299-01	Preferred	125 ml	—	AB	FDA listed	—
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 68788-8770-01	Preferred	125 ml	—	AB	FDA listed	—
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 71205-0036-12	Proficient	125 ml	—	AB	FDA listed	—
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 71205-0620-75	Proficient	75 ml	—	AB	FDA listed	—
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 82804-0017-12	Proficient	125 ml	—	AB	FDA listed	—
Augmentin Es-600 600 mg/5mL; 42.9 mg/5mL 81964-0003-51	USAntibiotics,	75 ml	—	AB	FDA listed	—
amoxicillin and clavulanate potassium 600 mg/5mL; 42.9 mg/5mL 62135-0095-13	Chartwell	125 ml	—	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

🏛️

2024

On the market since

Apr 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.

🔬 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

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

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 NDC	Description	Marketing start	Status
42571-0395-46	75 mL in 1 BOTTLE (42571-395-46)	2024-04-01	Discontinued by firm
42571-0395-70	125 mL in 1 BOTTLE (42571-395-70)	2024-04-01	Discontinued by firm
42571-0395-77 You're viewing this	200 mL in 1 BOTTLE (42571-395-77)	2024-04-01	Discontinued by firm

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

Pack size FAQ

What quantity is in NDC 42571-0395-77?

NDC 42571-0395-77 contains 200 mL — 200 ml in 1 bottle.

What is the difference between NDC 42571-0395-77 and NDC 42571-0395-46?

Both are Amoxicillin and clavulanate potassium 600 mg/5mL; 42.9 mg/5mL For Suspension — the drug itself is identical. NDC 42571-0395-77 is the 200 mL package, while NDC 42571-0395-46 is the 75 ml package.

What NDC number is used to bill for this package of Amoxicillin and clavulanate potassium 600 mg/5mL; 42.9 mg/5mL For Suspension?

Bill NDC 42571-0395-77 — the 11-digit billing format is 42571039577. 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 No longer marketed (per FDA listing data)

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)	— Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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.

What does the discontinued status mean for this NDC?

The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.

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 42571-395-77, 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: 42571-0395-77, written without dashes as 42571039577. 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 42571-0395-77, the first segment (42571) is the labeler code FDA assigned to Micro Labs Limited; the middle segment (0395) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (77) identifies this exact package size and type. Together they name one specific package of one specific product.

Does this product come in other package sizes?

Yes — the FDA directory lists 2 other package presentations of this same product, including 75 ml (42571-0395-46), 125 ml (42571-0395-70). 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?

Micro Labs Limited is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE Amoxicillin and clavulanate potassium for oral suspension is indicated for the treatment of pediatric patients aged 3 months to 12 years weighing less than or equal to 40 kg with: Recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs less than or equal to 2 mcg/mL), H. influenzae (including beta-lactamase-producing strains), or M. catarrhalis (including beta-lactamase-producing strains) characterized by the following risk factors: - Antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following: 1) age 2 years, or younger or 2) day care attendance [see Microbiology ( 12.4 )] .

Limitations of Use Amoxicillin and clavulanate potassium for oral suspension is not indicated for the treatment of acute otitis media due to S. pneumoniae with penicillin MIC greater than or equal to 4 mcg/mL. Acute otitis media due to S. pneumoniae alone can be treated with amoxicillin. Therapy may be instituted prior to obtaining the results from bacteriological studies when there is reason to believe the infection may involve both S. pneumoniae (penicillin MIC less than or equal to 2 mcg/mL) and the beta-lactamase-producing organisms listed above.

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 the treatment of pediatric patients aged 3 months to 12 years weighing less than or equal to 40 kg with Recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs less than or equal to 2 mcg/mL), H. influenzae (including beta-lactamase-producing strains), or M. catarrhalis (including beta-lactamase-producing strains) characterized by the following risk factors ( 1 ) : Antibacterial exposure for acute otitis media within the preceding 3 months, and either of the following: 1) age 2 years, or younger or 2) daycare attendance.

( 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 Pediatric Patients aged 3 months to 12 years weighing less than or equal to 40 kg: 90 mg/kg/day divided every 12 hours, administered for 10 days. ( 2 )

2.1Important Administration Instructions To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension should be taken at the start of a meal. Absorption of clavulanate potassium may be enhanced when amoxicillin and clavulanate potassium for oral suspension is administered at the start of a meal.

2.2Dosage in Pediatric Patients Pediatric patients aged 3 months to 12 years weighing less than or equal to 40 kg: Based on the amoxicillin component (600 mg/5 mL), the recommended dose of amoxicillin and clavulanate potassium for oral suspension is 90 mg/kg/day divided every 12 hours, administered for 10 days (see Table 1 as a general example guideline for attainment of this dosage). This dose provides 6.4 mg/kg/day of the clavulanic acid component. Table 1: General Dosage Guidelines for Amoxicillin and Clavulanate Potassium for Oral Suspension in Pediatric Patients Body Weight (kg) Volume of Amoxicillin and Clavulanate Potassium for Oral Suspension Providing 90 mg/kg/day 8 3 mL twice daily 12 4.5 mL twice daily 16 6 mL twice daily 20 7.5 mL twice daily 24 9 mL twice daily 28 10.5 mL twice daily 32 12 mL twice daily 36 13.5 mL twice daily 40 15 mL twice daily Pediatric patients weighing greater than 40 kg : Experience with amoxicillin and clavulanate potassium for oral suspension in this group is not available.

2.3Dosage in Adult Patients Experience with amoxicillin and clavulanate potassium for oral suspension in adults is not available and adults who have difficulty swallowing should not be given amoxicillin and clavulanate potassium for oral suspension in place of the 500 mg or 875 mg tablet of AUGMENTIN.

2.4Dosage in Patients with Hepatic Impairment Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals [see Warnings and Precautions ( 5.4 )] .

2.5Preparation of the Oral Suspension Prepare the suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Measure the total amount of water (see Table 2) to be added in two parts. Add approximately 2/3 of the total amount of water for reconstitution, replace cap and shake vigorously to suspend powder.

Add remainder of the water (that had been measured), replace cap and again shake vigorously. Table 2: Volume of Water for Reconstituting Amoxicillin and Clavulanate Potassium for Oral Suspension Bottle Size Amount of Water Required for Reconstitution 75 mL 62 mL 125 mL 103 mL 200 mL 165 mL Each 5 mL will contain 600 mg of amoxicillin as the trihydrate, and 42.9 mg of clavulanic acid as the potassium salt. Shake oral suspension well before each use.

Suspension must be refrigerated. Discard after 10 days. Suspension is white to off-white at time of reconstitution; some color change is normal during the dosing period.

Flavoring Information : For patients who wish to alter the taste of amoxicillin and clavulanate potassium for oral suspension, immediately after reconstitution, 1 drop of FLAVORx ® (apple, banana cream, bubble gum, cherry, or watermelon flavor) may be added for every 5 mL of amoxicillin and clavulanate potassium for oral suspension. The resulting suspension is stable for 10 days under refrigeration. Stability of amoxicillin and clavulanate potassium for oral suspension when mixed with other flavors other than the 5 flavors listed above has not been evaluated.

2.6Switching between Dosage Forms and between Strengths Amoxicillin and clavulanate potassium for oral suspension does not contain the same amount of clavulanic acid (as the potassium salt) as any of the other suspensions of AUGMENTIN. Amoxicillin and clavulanate potassium for oral suspension contains 42.9 mg of clavulanic acid per 5 mL, whereas the 200 mg/28.5 mg per 5 mL suspension of AUGMENTIN contains…

💊 Dosage Forms and Strengths 63 words ▾

3 DOSAGE FORMS AND STRENGTHS Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/42.9 mg per 5 mL: White to off-white, orange-flavored for oral suspension (each 5 mL of reconstituted suspension contains 600 mg of amoxicillin, USP as the trihydrate, and 42.9 mg of clavulanic acid as the potassium salt). For oral suspension: 600 mg/42.9 mg per 5 mL. ( 3 )

⛔ Contraindications 120 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 any 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 treatment 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 for oral suspension if a reaction occurs and institute appropriate therapy. ( 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. If this occurs, discontinue amoxicillin and clavulanate potassium 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) (ranging from mild diarrhea to fatal colitis): 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 )

5.1Serious Allergic Reactions, Including Anaphylaxis 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 concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens.

If an allergic reaction occurs, discontinue amoxicillin and clavulanate potassium for oral suspension and institute appropriate therapy.

5.2Severe Cutaneous Adverse Reactions Amoxicillin and clavulanate potassium for oral suspension 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 for oral suspension discontinued if lesions progress.

5.3Drug-Induced Enterocolitis Syndrome (DIES) Drug-induced enterocolitis syndrome (DIES) hasbeenreported with use of amoxicillin, a component of amoxicillin and clavulanate potassium for oral suspension [see Adverse Reactions (6.2)], withmost cases occurring in pediatric patients ≤ 18 years of age. DIES is a non-IgE mediated hypersensitivity reaction characterized byprotractedvomiting 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 after ingesting amoxicillin, and leukocytosis with neutrophilia.

If DIES occurs, discontinueamoxicillinand clavulanate potassium for oral suspension and institute appropriate therapy.

5.4Hepatic Dysfunction Use amoxicillin and clavulanate potassium for oral suspension with caution in patients with evidence of hepatic dysfunction. Hepatic toxicity associated with the use of amoxicillin and clavulanate potassium for oral suspension is usually reversible. Deaths have been reported (fewer than one death reported per estimated four million prescriptions worldwide).

These have generally been cases associated with serious underlying diseases or concomitant medications [see Contraindications ( 4.2 ) and Adverse Reactions ( 6.2 )] .

5.5Clostridioides difficile -Associated Diarrhea (CDAD) Clostridioides 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 wit…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: Anaphylactic reactions [see Warnings and Precautions ( 5.1 )] Severe Cutaneous Adverse Reactions (SCAR) [see Warnings and Precautions ( 5.2 )] Drug-Induced Enterocolitis Syndrome (DIES) [see Warnings and Precautions ( 5.3 )] Hepatic Dysfunction [see Warnings and Precautions ( 5.4 )] Clostridioides difficile- Associated Diarrhea (CDAD) [see Warnings and Precautions ( 5.5 )] Skin Rash in Patients with Mononucleosis [see Warnings and Precautions ( 5.6 )] The most frequently reported adverse reactions (incidence rate > 4 %) were coughing, vomiting, contact dermatitis (i.e., diaper rash), fever, upper respiratory tract infection, and diarrhea.

( 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. Two clinical trials evaluated the safety of a 10-day treatment course of amoxicillin and clavulanate potassium for oral suspension 90/6.4 mg/kg/day, divided every 12 hours, in pediatric patients with acute otitis media [see Clinical Studies (14)] .

The first trial involved 521 pediatric patients (3 months to 50 months) and the second trial involved 450 pediatric patients (3 months to 12 years). In the intent-to-treat population of the first trial of 521 patients, the most frequently reported adverse events were vomiting (7%), fever (6%), contact dermatitis (i.e., diaper rash) (6%), upper respiratory tract infection (4%), and diarrhea (4%). Protocol-defined diarrhea (i.e., 3 or more watery stools in one day or 2 watery stools per day for 2 consecutive days as recorded on diary cards) occurred in 13% of patients.

The primary objective of the second study was to compare the safety of amoxicillin and clavulanate potassium for oral suspension (90/6.4 mg/kg/day, divided every 12 hours) to AUGMENTIN (45/6.4 mg/kg/day, divided every 12 hours) for ten days. There was no statistically significant difference between treatments in the proportion of patients with 1 or more adverse events. The most frequently reported adverse reactions for amoxicillin and clavulanate potassium for oral suspension and the comparator of AUGMENTIN were coughing (12% versus 7%), vomiting (7% versus 8%), contact dermatitis (i.e., diaper rash, 6% versus 5%), fever (6% versus 4%), and upper respiratory infection (3% versus 9%), respectively.

The frequencies of protocol-defined diarrhea with amoxicillin and clavulanate potassium for oral suspension (11%) and AUGMENTIN (9%) were not statistically different. Two patients in the group treated with amoxicillin and clavulanate potassium for oral suspension and one patient in the group treated with AUGMENTIN were withdrawn due to diarrhea.

6.2Postmarketing Experience The following adverse reactions have been identified during postmarketing use of AUGMENTIN products, including amoxicillin and clavulanate potassium for oral suspension. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal: Drug-induced enterocolitis syndrome (DIES), diarrhea, nausea, vomiting, 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 ( 5.3 , 5.5 )]. Immune: Hypersensitivity reactions, anaphylactic/anaphylactoid reactions (including shock), angioedema, serum sickness-like reactions (urtica…

🔄 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 with oral anticoagulants may increase the prolongation of prothrombin time. ( 7.2 ) Co-administration 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. Concurrent use with amoxicillin and clavulanate potassium for oral suspension may result in increased and prolonged blood levels 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. 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 substantially 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. There are no data with amoxicillin and clavulanate potassium for oral suspension and allopurinol administered concurrently.

7.4Oral Contraceptives Amoxicillin and clavulanate potassium for oral suspension 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 for oral suspension, 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

8.1Pregnancy Risk Summary Available data from published epidemiologic studies and pharmacovigilance case reports over several decades of use with amoxicillin and clavulanate during pregnancy have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal outcomes. A study in women with preterm prelabor rupture of membranes (PPROM) reported that prophylactic treatment with amoxicillin and clavulanate may be associated with an increased risk of necrotizing enterocolitis in neonates (see Data) .

Reproduction studies performed in pregnant rodents, given up to approximately 2 times the amount of amoxicillin and 15 times the amount of clavulanate in the Maximum Human Recommended Dose (MHRD) of amoxicillin and clavulanate potassium for oral suspension, revealed no evidence of harm to the fetus (see Data) . The background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data One randomized, controlled trial included 4,826 pregnant women with premature rupture of fetal membranes who were randomly assigned to 250 mg erythromycin (n=1,197), 250 mg amoxicillin and 125 mg clavulanic acid (amoxicillin and clavulanate, n=1,212), amoxicillin and clavulanate and erythromycin (n=1,192), or placebo (n=1,225) four times daily for 10 days or until delivery.

Amoxicillin and clavulanate was associated with a significantly increased rate of proven neonatal necrotizing enterocolitis: 1.9% (n = 24) in the amoxicillin and clavulanate only group versus 0.5% (n = 6) in the placebo group (p = 0.001), and 1.8% (n = 44) in the any amoxicillin and clavulanate group versus 0.7% (n =17) in the no amoxicillin and clavulanate group (p = 0.0005). Animal Data Reproduction studies performed in pregnant rats and mice given amoxicillin and clavulanate (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.

The amoxicillin doses in rodents (based on body surface area and assuming a 20 kg child) were approximately 2 times (rats) or equal to (mice) the recommended clinical amoxicillin and clavulanate potassium for oral suspension dose of 90/6.4 mg/kg/day. For clavulanate, these dose multiples were approximately 15 times and 7.5 times the recommended daily dose of amoxicillin and clavulanate potassium for oral suspension.

8.2Lactation Risk Summary Data from a published clinical lactation study report that amoxicillin is present in human milk. There are reports of diarrhea, irritability, and rash in infants exposed to amoxicillin and clavulanate through breast milk; therefore, infants exposed to amoxicillin and clavulanate potassium for oral suspension should be monitored for these symptoms. There are no data on the effects of amoxicillin and clavulanate on milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for amoxicillin and clavulanate potassium for oral suspension and any potential adverse effects on the breastfed child from amoxicillin and clavulanate potassium for oral suspension or from the underlying maternal condition.

8.4Pediatric Use Acute Otitis Media The safety and effectiveness of amoxicillin and clavulanate potassium for oral suspension have been established in pediatric patients aged 3 months to 12 years weighing less than or equal to 40 kg, for the treatment of acute otitis media, and the information on this use is discussed throughout the labeling. The safety and effectiveness of amoxicillin and clavulanate potassium for oral suspension in pediatric patients younger than 3 months of age have n…

🤰 Pregnancy ~2 min read ▾

🧒 Pediatric Use 216 words ▾

Acute Bacterial Sinusitis The safety and effectiveness of amoxicillin and clavulanate potassium for oral suspension have been established for the treatment of pediatric patients (3 months to 12 years of age) with acute bacterial sinusitis. This use is supported by evidence from adequate and well-controlled studies of AUGMENTIN XR TM extended release tablets in adults with acute bacterial sinusitis, studies of amoxicillin and clavulanate potassium for oral suspension in pediatric patients with acute otitis media, and by similar pharmacokinetics of amoxicillin and clavulanate in pediatric patients taking amoxicillin and clavulanate potassium for oral suspension [see Clinical Pharmacology ( 12 )] and adults taking AUGMENTIN XR.

🆘 Overdosage ~1 min read ▾

10 OVERDOSAGE Following overdosage, patients have experienced primarily gastrointestinal symptoms including stomach and abdominal pain, vomiting, and diarrhea. Rash, hyperactivity, or drowsiness have also been observed in a small number of patients. In the case of overdosage, discontinue amoxicillin and clavulanate potassium for oral suspension, treat symptomatically, and institute supportive measures as required.

If the overdosage is very recent and there is no contraindication, an attempt at emesis or other means of removal of drug from the stomach may be performed. 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 and do not require gastric emptying. 1 Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdosage with amoxicillin.

Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin overdosage in adult and pediatric patients. In case of overdosage, adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin 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 both amoxicillin and clavulanate. Both amoxicillin and clavulanate are removed from the circulation by hemodialysis [see Dosage and Administration ( 2 )].

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Amoxicillin and clavulanate potassium for oral suspension is an antibacterial drug [see Microbiology ( 12.4 )].

12.3Pharmacokinetics The pharmacokinetics of amoxicillin and clavulanate were determined in a study of 19 pediatric patients, 8 months to 11 years, given amoxicillin and clavulanate potassium for oral suspension at an amoxicillin dose of 45 mg/kg q12h with a snack or meal. The mean plasma amoxicillin and clavulanate pharmacokinetic parameter values are listed in Table 3. Table 3.

Mean (±SD) Plasma Amoxicillin and Clavulanate Pharmacokinetic Parameter Values Following Administration of 45 mg/kg of Amoxicillin and Clavulanate Potassium for Oral Suspension Every 12 Hours to Pediatric Patients Parameter Amoxicillin Clavulanate C max (mcg/mL) 15.7 ± 7.7 1.7 ±

0.9T max (hr) 2.0 (1.0 to 4.0) 1.1 (1.0 to 4.0) AUC 0-T (mcg * hr/mL) 59.8 ± 20.0 4.0 ±

1.9T ½ (hr) 1.4 ± 0.3 1.1 ±

0.3CL/F (L/hr/kg) 0.9 ± 0.4 1.1 ± 1.1 * Arithmetic mean ± standard deviation, except T max values which are medians (ranges). The effect of food on the oral absorption of amoxicillin and clavulanate potassium for oral suspension has not been studied. Approximately 50% to 70% of the amoxicillin and approximately 25% to 40% of the clavulanic acid are excreted unchanged in urine during the first 6 hours after administration of 10 mL of 250 mg/5 mL suspension of AUGMENTIN.

Neither component in amoxicillin and clavulanate potassium for oral suspension is highly protein-bound; clavulanic acid has been found to be approximately 25% bound to human serum and amoxicillin approximately 18% bound. Oral administration of a single dose of amoxicillin and clavulanate potassium for oral suspension at 45 mg/kg (based on the amoxicillin component) to pediatric patients, 9 months to 8 years, yielded the following pharmacokinetic data for amoxicillin in plasma and middle ear fluid (MEF): Table 4. Amoxicillin Concentrations in Plasma and Middle Ear Fluid Following Administration of 45 mg/kg of Amoxicillin and Clavulanate Potassium for Oral Suspension to Pediatric Patients * Timepoint Amoxicillin concentration in plasma (mcg/mL) Amoxicillin concentration in MEF (mcg/mL) 1 hour mean median range 7.7 9.3 1.5 to 14.0 (n = 5) 3.2 3.5 0.2 to 5.5 (n = 4) 2 hour mean median range 15.7 13.0 11.0 to 25.0 (n = 7) 3.3 2.4 1.9 to 6 (n = 5) 3 hour mean median range 13.0 12.0 5.5 to 21.0 (n = 5) 5.8 6.5 3.9 to 7.4 (n = 5) * Dose administered immediately prior to eating.

Amoxicillin diffuses readily into most body tissues and fluids, with the exception of the brain and spinal fluid. The results of experiments involving the administration of clavulanic acid to animals suggest that this compound, like amoxicillin, is well distributed in body tissues. Drug Interaction Studies Clinical Studies Concurrent administration of probenecid delays amoxicillin excretion but does not delay renal excretion of clavulanic acid.

12.4Microbiology Mechanism of Action Amoxicillin is a semisynthetic antibacterial with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Amoxicillin is, however, susceptible to degradation by beta-lactamases, and therefore, its spectrum of activity does not include organisms which produce these enzymes. Clavulanic acid is a beta-lactam, structurally related to penicillin, which possesses the ability to inactivate a wide range of beta-lactamase enzymes commonly found in microorganisms resistant to penicillins and cephalosporins.

In particular, it has good activity against the clinically important plasmid-mediated beta-lactamases frequently found responsible for transferred drug resistance. The clavulanic acid component of amoxicillin and clavulanate potassium for oral suspension protects amoxicillin from degradation by beta-lactamase enzymes and effectively extends the antibacterial spectrum of amoxicillin to include many bacteria normally resistant to amoxicillin and other bet…

🧬 Mechanism of Action 20 words ▾

12.1Mechanism of Action Amoxicillin and clavulanate potassium for oral suspension is an antibacterial drug [see Microbiology ( 12.4 )].

📦 How Supplied / Storage and Handling 112 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/42.9 mg per 5 mL: White to off-white, orange-flavored powder for oral suspension. Following constitution, each 5 mL of oral suspension contains 600 mg of amoxicillin, USP as the trihydrate and 42.9 mg of clavulanic acid as the potassium salt (equivalent to 51.1 mg of clavulanate potassium). NDC 42571-395-46 75 mL bottle NDC 42571-395-70 125 mL bottle NDC 42571-395-77 200 mL bottle Storage Store dry powder for oral suspension at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dispense in original container. Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days.

📋 Description ~1 min read ▾

11 DESCRIPTION Amoxicillin and clavulanate potassium for oral suspension USP, 600 mg/42.9 mg per 5 mL is an oral antibacterial combination consisting of the semisynthetic antibacterial 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, USP molecular formula is C 16 H 19 N 3 O 5 S•3H 2 O, and the molecular weight is 419.4.

Chemically, amoxicillin is (2 S ,5 R ,6 R )-6-[( R )-2-amino-2-(4-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 a wide variety of beta-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated beta-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins.

The clavulanate potassium molecular formula is C 8 H 8 KNO 5 and the molecular weight is 237.3. Chemically, clavulanate potassium is potassium ( Z )-(2 R ,5 R )-3-(2-Hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylic acid and may be represented structurally as: Following constitution, each 5 mL of oral suspension contains 600 mg of amoxicillin, USP as the trihydrate and 42.9 mg of clavulanic acid (equivalent to 51.1 mg of clavulanate potassium). Inactive Ingredients: Aspartame, citric acid anhydrous, colloidal silicon dioxide, hypromellose, mannitol, orange flavour, trisodium citrate dihydrate, and xanthan gum [see Warnings and Precautions ( 5.8 )] .

Each 5 mL of reconstituted amoxicillin and clavulanate potassium for oral suspension USP, 600 mg/42.9 mg per 5 mL contains 0.23 mEq potassium. amoxi-strua.jpg amoxi-strub.jpg

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Administration Instructions Inform patients to take amoxicillin and clavulanate potassium for oral suspension every 12 hours with a meal or snack to reduce the possibility of gastrointestinal upset. If diarrhea develops and is severe or lasts more than 2 or 3 days, they should call their doctor [see Dosage and Administration ( 2.1 ), Warnings and Precautions ( 5.5 )] . Allergic Reactions Counsel patients that amoxicillin and clavulanate potassium for oral suspension contains a penicillin class drug product that can cause allergic reactions in some individuals [see Warnings and Precautions ( 5.1 , 5.3 )] .

Severe Cutaneous Adverse Reactions (SCAR ) Advise patients about the signs and symptoms of serious skin manifestations. Instruct patients to stop taking amoxicillin and clavulanate potassium for oral suspension immediately and promptly report the first signs or symptoms of skin rash, mucosal lesions, or any other sign of hypersensitivity [see Warnings and Precautions ( 5.2 )]. Diarrhea Counsel patients that diarrhea is a common problem caused by antibacterial drugs, including amoxicillin and clavulanate potassium for oral suspension, which usually ends when the antibacterial is discontinued.

Sometimes after starting treatment with antibacterial drugs, 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 the last dose of the antibacterial drug. If this occurs, patients should contact their physician as soon as possible [see Warnings and Precautions ( 5.5 )] . Phenylketonuria Counsel patients with phenylketonuria: Each 5 mL of suspension of amoxicillin and clavulanate potassium for oral suspension contains 9 mg phenylalanine [see Warnings and Precautions ( 5.8 )] .

Antibacterial Resistance Patients should be counseled that antibacterial drugs, including amoxicillin and clavulanate potassium for oral suspension, should only be used to treat bacterial infections. Antibacterial drugs do not treat viral infections (e.g., the common cold). When amoxicillin and clavulanate potassium for oral suspension is 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 for oral suspension or other antibacterial drugs in the future [see Warnings and Precautions ( 5.9 )] . Storage Instructions Keep suspension refrigerated. Shake well before using.

When dosing a child with the suspension (liquid) of amoxicillin and clavulanate potassium for oral suspension, 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 for oral suspension 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. AUGMENTIN and AUGMENTIN XR are registered trademarks of GlaxoSmithKline.

CLINITEST is a registered trademark of Miles, Inc. FLAVORx is a registered trademark of FLAVORx. Inc.

Manufactured by: Micro Labs Limited INDIA. Manufactured for: Micro Labs USA, Inc. Somerset, NJ 08873 Rev.

01/2025

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

contraindication: A situation in which a medicine should not be used because the risk is considered too high.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

bactericidal: Describes a medicine that kills bacteria outright.

candidiasis: An infection caused by a yeast called Candida, which can affect the mouth, throat, skin, or other areas.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Clostridioides difficile: A type of gut germ that can overgrow and cause severe, watery diarrhea, often after antibiotic use.

colitis: Swelling and irritation of the inner lining of the large intestine, or colon.

contact dermatitis: A skin rash caused by touching something that irritates the skin or triggers an allergy.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

dermatitis: Inflammation of the skin, causing redness, itching, and sometimes swelling or blisters.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

emesis: The medical word for vomiting, or bringing up the contents of the stomach through the mouth.

eosinophilia: A higher-than-normal level of eosinophils, a type of white blood cell often linked to allergies or drug reactions.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

gastritis: Swelling or irritation of the lining of the stomach.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

hepatitis: Inflammation of the liver, which can be caused by infections, alcohol, or certain medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hyperuricemia: A higher-than-normal level of uric acid in the blood, which can lead to gout.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

INR: A blood test result that shows how quickly blood clots, often used to monitor blood-thinning medicines.

interstitial nephritis: Inflammation of the tissue between the kidney's tiny filtering tubes, sometimes triggered by a medicine, that can reduce kidney function.

irritability: Getting annoyed, frustrated, or angry more easily than usual.

jaundice: Yellowing of the skin and the whites of the eyes caused by too much bilirubin in the blood.

lactation: The making and release of milk from a mother's breasts after giving birth.

lethargy: A state of tiredness and sluggishness, often with slowed thinking or movement.

leukocytosis: A higher-than-normal level of white blood cells, often a sign the body is fighting an infection.

liver function tests: Blood tests that check how well the liver is working and whether it is irritated or damaged.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

mucocutaneous: Involving both the skin and the moist linings of the body, such as the mouth, eyes, or nose.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neonatal: Relating to a newborn baby during its first four weeks of life.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

pallor: Unusual paleness of the skin.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

prothrombin time: A blood test that measures how many seconds it takes for blood to form a clot.

pseudomembranous colitis: A serious swelling of the large intestine, usually caused by C. difficile bacteria, that leads to severe diarrhea.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

reconstitution: Mixing a powdered medicine with a liquid to prepare it for use, following the label's directions.

renal excretion: Removal of a medicine from the body through the kidneys into the urine.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

serum sickness: A delayed reaction, usually one to two weeks after exposure, causing fever, rash, and joint pain as the body reacts to a foreign substance.

statistically significant: A result unlikely to be due to chance alone, suggesting a real difference between the groups being compared.

Stevens-Johnson syndrome: A rare, serious reaction causing painful blistering and peeling of the skin and the moist linings of the mouth, eyes, and other areas.

stomatitis: Soreness, swelling, or sores on the lining inside the mouth.

suspension: A liquid holding fine drug particles that are mixed in but not fully dissolved, so it must be shaken before use.

toxic epidermal necrolysis: A rare, life-threatening reaction in which large areas of the top layer of skin blister and peel away, like a severe burn.

upper respiratory tract infection: An infection of the nose, sinuses, or throat, such as the common cold.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

← 42571-0394-89 · Micro 42571-0396-39 · Micro →

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.

Amoxicillin and clavulanate potassium 600 mg/5mL; 42.9 mg/5mL For Suspension, 200 mL

🆔 Identity & classification

🏷️ RxNorm drug class

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

🔬 Reported adverse events (FAERS)

Top reported reactions

Age at onset

Reporter sex

Serious outcomes

📦 Packaging — all sizes for this product

Pack size FAQ

🧭 About this NDC listing & data coverage

Questions about this listing

📄 Full prescribing information FDA SPL

8 USE IN SPECIFIC POPULATIONS

12 CLINICAL PHARMACOLOGY

🔗 Related NDC lookups