Quick answers
- What is Amoxicillin and clavulanate potassium (amoxicillin / clavulanic acid) (3) used for?
- The FDA-approved label (Amoxicillin and Clavulanate Potassium, Hikma Pharmaceuticals USA Inc., February 28, 2025) says: “Amoxicillin and Clavulanate Potassium for Oral Suspension is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: • Lower Respiratory Tract Infections -caused by beta‑lactamase‑producing isolates of Haemophilus influenzae and Moraxella catarrhalis. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Amoxicillin and clavulanate potassium (amoxicillin / clavulanic acid) (3)?
- The “Adverse Reactions” section of the FDA label (Amoxicillin and Clavulanate Potassium, Hikma Pharmaceuticals USA Inc., February 28, 2025) begins: “The following are discussed in more detail in other sections of the labeling: • Anaphylactic reactions [see Warnings and Precautions (5.1)] • Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.2)] • 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)] The most frequently reported …” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the drug interactions of Amoxicillin and clavulanate potassium (amoxicillin / clavulanic acid) (3)?
- The “Drug Interactions” section of the FDA label (Amoxicillin and Clavulanate Potassium, Hikma Pharmaceuticals USA Inc., February 28, 2025) begins: “• Co-administration with probenecid is not recommended. (7.1) • Concomitant use of amoxicillin and clavulanate potassium for oral suspension and oral anticoagulants may increase the prolongation of prothrombin time. (7.2) • Coadministration with allopurinol increases the risk of rash. (7.3) • Amoxicillin and clavulanate potassium for oral suspension may reduce efficacy of oral contraceptives.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Amoxicillin and clavulanate potassium (amoxicillin / clavulanic acid) (3) have a boxed warning?
- No. None of the 5 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Amoxicillin and clavulanate potassium (amoxicillin / clavulanic acid) (3)?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Amoxicillin and clavulanate potassium (amoxicillin / clavulanic acid) (3) been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Amoxicillin and clavulanate potassium (amoxicillin / clavulanic acid) (3)?
- 5 companies list prescription products of Amoxicillin and clavulanate potassium (amoxicillin / clavulanic acid) (3) in the FDA NDC Directory, including Hikma Pharmaceuticals USA Inc., A-S Medication Solutions and NuCare Pharmaceuticals, Inc.
What Amoxicillin and clavulanate potassium (amoxicillin / clavulanic acid) (3) is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Amoxicillin and Clavulanate Potassium for Oral Suspension is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: • Lower Respiratory Tract Infections -caused by beta‑lactamase‑producing isolates of Haemophilus influenzae and Moraxella catarrhalis. …
— FDA label: Amoxicillin and Clavulanate Potassium, Hikma Pharmaceuticals USA Inc., effective February 28, 2025. Read the full label on DailyMed →
Label quoted: the one for the most common form (powder, for suspension, oral), Amoxicillin and Clavulanate Potassium, Hikma Pharmaceuticals USA Inc.; it covers 2 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 5 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 5 FDA labels for this medicine have a boxed warning.
Amoxicillin and clavulanate potassium (amoxicillin / clavulanic acid) (3) side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
The following are discussed in more detail in other sections of the labeling:
- Anaphylactic reactions [see Warnings and Precautions (5.1)]
- Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.2)]
- 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)] The most frequently reported …
— FDA label: Amoxicillin and Clavulanate Potassium, Hikma Pharmaceuticals USA Inc., effective February 28, 2025. This is part of the section. Read the full label on DailyMed →
Amoxicillin and clavulanate potassium (amoxicillin / clavulanic acid) (3) drug interactions
Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.
- Co-administration with probenecid is not recommended. (7.1)
- Concomitant use of amoxicillin and clavulanate potassium for oral suspension and oral anticoagulants may increase the prolongation of prothrombin time. (7.2)
- Coadministration with allopurinol increases the risk of rash. (7.3)
- Amoxicillin and clavulanate potassium for oral suspension may reduce efficacy of oral contraceptives.
Read more of this section
(7.4) 7.1 Probenecid 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. 7.2 Oral 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. 7.3 Allopurinol 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. 7.4 Oral Contraceptives Amoxicillin and clavulanate potassium may affect intestinal flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives. 7.5 Effects 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.
— FDA label: Amoxicillin and Clavulanate Potassium, Hikma Pharmaceuticals USA Inc., effective February 28, 2025. Read the full label on DailyMed →
Amoxicillin and clavulanate potassium (amoxicillin / clavulanic acid) (3) dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
- Adults and Pediatric Patients greater than 40 kg: 500 or 875 mg every 12 hours or 250 or 500 mg every 8 hours, based on amoxicillin component. (2.2, 2.3)
- Pediatric patients aged 12 weeks (3 months) and older: 25 to 45 mg/kg/day every 12 hours or 20 to 40 mg/kg/day every 8 hours, up to the adult dose. (2.3)
- Neonates and infants less than 12 weeks of age: 30 mg/kg/day divided every 12 hours, based on the amoxicillin component.
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Use of the 125 mg/5 mL oral suspension is recommended. (2.3) 2.1 Important Administration Instructions Amoxicillin and clavulanate potassium suspension may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium suspension is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and clavulanate potassium suspension should be taken at the start of a meal. 2.2 Adult Patients See dosing regimens of Amoxicillin and clavulanate potassium suspension (based on the amoxicillin component) provided in Table 1 below. Table 1. Dosing Regimens of Amoxicillin and clavulanate potassium in Adult Patients TYPE OF INFECTION DOSING REGIMEN OF Amoxicillin and clavulanate potassium Severe infections and infections of the respiratory tract one 875 mg tablet a of Amoxicillin and clavulanate potassium every 12 hours or one 500 mg tablet b,c of Amoxicillin and clavulanate potassium every 8 hours Less severe infections one 500 mg tablet b,c of Amoxicillin and clavulanate potassium every 12 hours or one 250 mg tablet d of Amoxicillin and clavulanate potassium every 8 hours a Adults who have difficulty swallowing may be given the Amoxicillin and clavulanate potassium 200 mg/28.5 mg per 5 mL suspension or the Amoxicillin and clavulanate potassium 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet. b Adults who have difficulty swallowing may be given the Amoxicillin and clavulanate potassium 125 mg/31.25 mg per 5 mL or Amoxicillin and clavulanate potassium 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. c Two Amoxicillin and clavulanate potassium 250 mg/125 mg tablets are NOT substitutable with one 500 mg/125 mg Amoxicillin and clavulanate potassium tablet [see Dosage and Administration (2.6)]. d Amoxicillin and clavulanate potassium 250 mg/125 mg tablet is NOT substitutable with Amoxicillin and clavulanate potassium 250 mg/62.5 mg chewable tablet [see Dosage and Administration (2.6)]. 2.3 Pediatric Patients Based on the amoxicillin component, amoxicillin and clavulanate potassium suspension should be dosed as follows: Neonates and Infants Aged less than 12 weeks (less than 3 months): See dosing regimens of Amoxicillin and clavulanate potassium suspension provided in Table 2 below.
Table from the label
| TYPE OF INFECTION | DOSING REGIMEN OF Amoxicillin and clavulanate potassium |
|---|---|
| Severe infections and infections of the respiratory tract | one 875 mg tableta of Amoxicillin and clavulanate potassium every 12 hoursorone 500 mg tabletb,c of Amoxicillin and clavulanate potassium every 8 hours |
| Less severe infections | one 500 mg tabletb,c of Amoxicillin and clavulanate potassium every 12 hoursorone 250 mg tabletd of Amoxicillin and clavulanate potassium every 8 hours |
— FDA label: Amoxicillin and Clavulanate Potassium, Hikma Pharmaceuticals USA Inc., effective February 28, 2025. This is part of the section. Read the full label on DailyMed →
Amoxicillin and clavulanate potassium (amoxicillin / clavulanic acid) (3) in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.
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.
Read more of this section
The amoxicillin doses in rats and mice (based on body surface area) were approximately 4 and 2 times the maximum recommended adult human oral dose (875 mg every 12 hours). For clavulanate, these dose multiples were approximately 9 and 4 times the maximum recommended adult human oral dose (125 mg every 8 hours). There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
— FDA label: Amoxicillin and Clavulanate Potassium, Hikma Pharmaceuticals USA Inc., effective February 28, 2025. Read the full label on DailyMed →
Amoxicillin and clavulanate potassium (amoxicillin / clavulanic acid) (3) and breastfeeding
Quoted from the nursing mothers / lactation part of the FDA-approved label.
Amoxicillin has been shown to be excreted in human milk. Amoxicillin/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.
— FDA label: Amoxicillin and Clavulanate Potassium, Hikma Pharmaceuticals USA Inc., effective February 28, 2025. Read the full label on DailyMed →
When Amoxicillin and clavulanate potassium (amoxicillin / clavulanic acid) (3) should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
- 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) (4.1)
- History of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium for oral suspension.
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(4.2) 4.1 Serious Hypersensitivity Reactions Amoxicillin and clavulanate potassium 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). 4.2 Cholestatic Jaundice/Hepatic Dysfunction Amoxicillin and clavulanate potassium suspension is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium suspension.
— FDA label: Amoxicillin and Clavulanate Potassium, Hikma Pharmaceuticals USA Inc., effective February 28, 2025. Read the full label on DailyMed →
Amoxicillin and clavulanate potassium (amoxicillin / clavulanic acid) (3) overdose
Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).
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/clavulanate potassium.
Read more of this section
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/clavulanate potassium crystalluria. Renal impairment appears to be reversible with cessation of drug administration. High blood levels may occur more readily in patients with impaired renal function because of decreased renal clearance of amoxicillin and clavulanate potassium. Amoxicillin and clavulanate potassium may be removed from circulation by hemodialysis [see Dosage and Administration (2.4)].
— FDA label: Amoxicillin and Clavulanate Potassium, Hikma Pharmaceuticals USA Inc., effective February 28, 2025. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Powder, for suspension |
|---|---|
| Route | Oral |
| Prescription products | 6 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| amoxicillin 200 mg/5 mL · clavulanic acid 28.5 mg/5 mL powder, for suspension | Generic | $0.0467–$0.0686 per mL 3 packages, lowest to highest |
| amoxicillin 400 mg/5 mL · clavulanic acid 57 mg/5 mL powder, for suspension | Generic | $0.0556–$0.0789 per mL 3 packages, lowest to highest |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Hikma Pharmaceuticals USA Inc.2 products
- A-S Medication Solutions1 product
- NuCare Pharmaceuticals, Inc.1 product
- Preferred Pharmaceuticals Inc.1 product
- Proficient Rx LP1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (1)
- ANDA065191Hikma Pharms · January 25, 2005
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 617423, 617430 |
|---|---|
| SPL set ID of the quoted label | 240bcdcb-31d9-40a0-87e1-bd16264a2e20 |
| FDA labels (SPL) | 5 |
| FDA applications | 1 ANDA |
| Active ingredients (FDA) | AMOXICILLIN / CLAVULANIC ACID |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
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- Hikma Pharmaceuticals USA Inc.Maker or distributor
- A-S Medication SolutionsMaker or distributor
- NuCare Pharmaceuticals, Inc.Maker or distributor
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Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Amoxicillin and Clavulanate Potassium, Hikma Pharmaceuticals USA Inc., effective February 28, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →