Amoxicillin is a penicillin-class antibacterial sold in the U.S. under 4 brand and generic names, for actinomycosis, human bites and chlamydia infections. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Amoxicillin (application ANDA065271). Other amoxicillin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
In Adults, 750 to 1750 mg/day in divided doses every 8 to 12 hours. • In Pediatric Patients over 3 Months of Age, 20 to 45 mg/kg/day in divided doses every 8 to 12 hours. Refer to full prescribing information for specific dosing regimens. ( 2.2 , 2.3 ) • The upper dose for neonates and infants aged 3 months or younger is 30 mg/kg/day divided every 12 hours. ( 2.3 ) • Dosing for H. pylori Infection (in Adults): Triple therapy: 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. Dual therapy: 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. ( 2.4 ) • Reduce the dose in patients with severe renal impairment (GFR greater than 30 mL/min). (2.5) 2.1 Important Administration Instructions To minimize the potential for gastrointestinal intolerance, amoxicillin capsules should be taken at the start of a meal. 2.2 Dosage for Adults and Pediatric Patients Aged 3 Months (12 weeks) and Older • Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic, or evidence of bacterial eradication has been obtained. • It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. • In some…
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) ] • Clostridioides difficile -Associated Diarrhea (CDAD) [see Warnings and Precautions (5.3) ] The most common adverse reactions (greater than 1%) observed in clinical trials of amoxicillin capsules, tablets or for oral suspension were diarrhea, rash, vomiting, and nausea. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical 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 common adverse reactions (greater than 1%) observed in clinical trials of amoxicillin capsules, tablets or oral suspension were diarrhea, rash, vomiting, and nausea. Triple therapy: The most frequently reported adverse events for patients who received triple therapy (amoxicillin/clarithromycin/ lansoprazole) were diarrhea (7%), headache (6%), and taste perversion (5%). Dual therapy: The most frequently reported adverse events for patients who received…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Suspension | Generic | $0 | View → | |
| 2 | 64/100 | Prescription | Capsule | Generic |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| I07 | 875 mg / 125 mg | white | capsule | — |
| I07 | 875 mg / 125 mg | white | capsule | — |
| X;3;2 | 875 mg / 125 mg | white | capsule | — |
| A45 | 500 mg | blue, pink | capsule | — |
| 93;22;75 | 875 mg / 125 mg | white | oval | — |
| X;3;2 | 875 mg / 125 mg |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
The elimination half-life of amoxicillin is about 1 hour (roughly 61 minutes). The half-life is longer in newborns and young infants and in people with reduced kidney function, because amoxicillin is cleared mainly unchanged by the kidneys; it has no active metabolite.
Amoxicillin capsule label (DailyMed) ↗Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Amoxicillin capsules are contraindicated in patients who have experienced a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin capsules or to other β-lactam antibacterial drugs (e.g., penicillins and cephalosporins). • History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin capsules or to other beta-lactams (e.g., penicillins or cephalosporins). (4)
Co-administration with probenicid is not recommended. ( 7.1 ) • Concomitant use of amoxicillin and oral anticoagulants may increase the prolongation of prothrombin time. ( 7.2 ) • Co-administration with allopurinol increases the risk of rash. ( 7.3 ) • Amoxicillin may reduce the efficacy of oral contraceptives. ( 7.4 ) 7.1 Probenecid Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use of amoxicillin and probenecid may result in increased and prolonged blood levels of amoxicillin. 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. 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 rashes is due to allopurinol or the hyperuricemia present in these patients. 7.4 Oral Contraceptives Amoxicillin may affect the intestinal flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral…
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| 3 | 46/100 | Prescription | Suspension | Generic | $0 | View → |
| 4 | Not yet rated | Prescription | Suspension | Generic | $0 | View → |
| white |
| capsule |
| — |
| RHB;105 | 10 mg / 250 mg / 12.5 mg | orange | capsule | — |
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| A;6;7 | 875 mg | pink | oval | — |
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