Amoxicillin and Clavulanate Potassium 250 mg/5mL; 62.5 mg/5mL Powder, For Suspension, 75 mL
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the beta Lactamase Inhibitor class.
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🩺 Clinical
- 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?
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🧪 Inactive Ingredients / Excipients
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Acacia is a natural gum derived from acacia tree sap. It serves as a binder, thickener, and emulsifier to help hold ingredients together, improve texture, and stabilize the medicine.
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Hypromellose 2910 is a plant-derived cellulose compound used as a thickener and film-former in medicines. It helps control how quickly the medication dissolves and creates protective coatings on tablets or capsules.
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💲 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 | $0.445 | $33.34 / 75 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.5253 | $39.40 / 75 ml |
| Medicare drug plans payPart D · Q2 2026 | $0.4412 | $33.09 / 75 ml |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Amoxicillin and Clavulanate potassium 250 mg/5mL; 62.5 mg/5mL 69097-0098-08 | Cipla | 150 ml | $0.407 | AB | Availability likely | save 8% |
| Amoxicillin and Clavulanate Potassium 250 mg/5mL; 62.5 mg/5mLthis 59651-0026-75 | Aurobindo | 75 ml | $0.445 | AB | Availability likely | — |
| amoxicillin and clavulanate potassium 250 mg/5mL; 62.5 mg/5mL 73043-0010-01 | Devatis, | 75 ml | $0.445 | AB | Availability likely | — |
| Amoxicillin And Clavulanate Potassium 250 mg/5mL; 62.5 mg/5mL 81964-0204-07 | USAntibiotics, | 75 ml | $0.445 | AB | Availability likely | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 59651-0026-01 | 100 mL in 1 BOTTLE (59651-026-01) | $0.4484 / mL | $44.84 | 2019-04-19 | Active |
| 59651-0026-55 | 150 mL in 1 BOTTLE (59651-026-55) | $0.4075 / mL | $61.12 | 2019-04-19 | Active |
| 59651-0026-75 You're viewing this | 75 mL in 1 BOTTLE (59651-026-75) | $0.4445 / mL | $33.34 | 2019-04-19 | Active |
You're viewing the smallest of 3 pack sizes for this product.
Per mL, this pack runs about 9% above the cheapest pack (150 mL, $0.4075 vs $0.4445 NADAC).
This pack accounts for about 15% of this product's recent Medicaid fills; most go to the 100 ml pack. See all packs ↓
Pack size FAQ
What quantity is in NDC 59651-0026-75?
What is the difference between NDC 59651-0026-75 and NDC 59651-0026-01?
What NDC number is used to bill for this package of Amoxicillin and Clavulanate Potassium 250 mg/5mL; 62.5 mg/5mL Powder, For Suspension?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE 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 infections caused by designated susceptible (confirmed or suspected) beta-lactamase-producing microorganisms ( 1 ): Lower Respiratory Tract Infections ( 1.1 ) Amoxicillin and Clavulanate Potassium for Oral Suspension: pediatric patients weighing less than 40 kg, and in adult and pediatric patients who cannot swallow tablets Acute Bacterial Sinusitis ( 1.3 ) Amoxicillin and Clavulanate Potassium for Oral Suspension: pediatric patients weighing less than 40 kg, and in adult and pediatric patients who cannot swallow tablets Acute Bacterial Otitis Media ( 1.4 ) Amoxicillin and Clavulanate Potassium for Oral Suspension: pediatric patients weighing less than 40 kg, and in adult and pediatric patients who cannot swallow tablets Skin and Skin Structure Infections ( 1.6 ) Amoxicillin and Clavulanate Potassium for Oral Suspension: pediatric patients weighing less than 40 kg, and in adult and pediatric patients who cannot swallow tablets Urinary Tract Infections ( 1.7 ) Amoxicillin and Clavulanate Potassium for Oral Suspension: pediatric patients weighing less than 40 kg, and in adult and pediatric patients who cannot swallow tablets Limitations of Use ( 1.8 ) Therapy may be initiated before bacteriological results are available when beta-lactamase-producing pathogens are suspected.
When results show susceptibility to amoxicillin alone, amoxicillin and clavulanate potassium for oral suspension should not be used. Usage to Reduce Development of Drug-Resistant Bacteria ( 1.9 ) 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.
1.1Lower Respiratory Tract Infections Amoxicillin and clavulanate potassium for oral suspension is indicated for the treatment of lower respiratory tract infection due to confirmed or suspected beta-lactamase producing Haemophilus influenzae and Moraxella catarrhalis as follows [see Clinical Pharmacology (12.4) , Clinical Studies (14.1) ] : Amoxicillin and Clavulanate Pot assi um for Oral Suspension: pediatric patients weighing less than 40 kg, and in adult and pediatric patients who cannot swallow tablets
1.3Acute Bacterial Sinusitis Amoxicillin and clavulanate potassium for oral suspension are indicated for the treatment of acute bacterial sinusitis due to confirmed or suspected beta-lactamase-producing Haemophilus influenzae and Moraxella catarrhalis as follows [see Clinical Pharmacology (12.4) , Clinical Studies (14.4) ]: Amoxicillin and Clavulanate Po tassi um for Oral Suspension: pediatric patients weighing less than 40 kg, and in adult and pediatric patients who cannot swallow tablets
1.4Acute Bacterial Otitis Media Amoxicillin and clavulanate potassium for oral suspension is indicated for the treatment of acute bacterial otitis media due to confirmed or suspected beta-lactamase-producing Haemophilus influenzae and Moraxella catarrhalis as follows [see Use in Specific Populations (8.4) , Clinical Studies (14.5) ] : Amoxicillin and Clavulanate Pot assi um for Oral Suspension: pediatric patients weighing less than 40 kg, and in adult and pediatric patients who cannot swallow tablets
1.6Skin and Skin Structure Infections Amoxicillin and clavulanate potassium for oral suspension is indicated for the treatment of skin and skin structure infections due to confirmed or suspected beta-lactamase-producing S. aureus , Escherichia coli , and Klebsiella species as follows [see Use in Specific Populations (8.4) ] : Amoxicillin and Clav ulana te Potassium for Oral Suspension: pediatric…
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Recommended dosage and administration for the amoxicillin and clavulanate potassium depends on the indication, patient age, weight, and ability to swallow tablets. Therefore, carefully follow the recommended dosage and administration instructions specified below. Pediatric Patients less than 3 Months of Age : 30 mg/kg/day divided into 2 doses every 12 hours using amoxicillin and clavulanate potassium for oral suspension 125 mg/31.25 mg per 5 mL ( 2.3 ) Pediatric Patients 3 Months and Older and Weighing Less Than 40 kg ( 2.4 ) Infection Type Frequency Dose Formulation Strength Amoxicillin and Clavulanate Potassium for Oral Suspension Mild to Moderate Infections Every 12 hours 25 mg/kg/day divided into 2 doses 200 mg/28.5 mg or 400 mg/57 mg Every 8 hours 20 mg/kg/day divided into 3 doses 125 mg/31.25 mg or 250 mg/62.5 mg Severe Infections Every 12 hours 45 mg/kg/day divided into 2 doses 200 mg/28.5 mg or 400 mg/57 mg Every 8 hours 40 mg/kg/day divided into 3 doses 125 mg/31.25 mg or 250 mg/62.5 mg Adjust dose for severe renal impairment (GFR less than 30 mL/min) and in patients on hemodialysis.
( 2.6 , 8.6 , 12.3 ) See full Prescribing Information for preparation of oral suspension. ( 2.7 , 2.8 )
2.1Important Administration Instructions The recommended dosage and administration for the amoxicillin and clavulanate potassium, depends on the indication, patient age, weight, and ability to swallow tablets. Therefore, carefully follow the recommended dosage and administration instructions specified below [see Dosage and Administration (2.3 , 2.4 , 2.6 to 2.8) ]. Substitution among amoxicillin and clavulanate potassium formulations should only occur when the amoxicillin-to-clavulanic acid ratio is matched; AUGMENTIN Chewable Tablets and Amoxicillin and Clavulanate Potassium for Oral Suspension are substitutable on a mg-per-mg basis, and certain AUGMENTIN Tablet strengths are substitutable with specific Amoxicillin and Clavulanate Potassium for Oral Suspension or AUGMENTIN Chewable Tablet strengths. [see Dosage and Administration (2.8) ].
2.3Recommended Dosage of Amoxicillin and Clavulanate Potassium for Oral Suspension in Pediatric Patients Less Than 3 Months of Age Amoxicillin and clavulanate potassium 125 mg/31.25 mg per 5 mL for oral suspension is the recommended formulation for use in this pediatric age group [see Use in Specific Populations (8.4) ] . The recommended dosage for pediatric patients less than 3 months of age, based on the amoxicillin component, is 30 mg/kg/day orally divided into two doses every 12 hours. Amoxicillin and clavulanate potassium for oral suspension may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium for oral suspension is administered at the start of a meal.
To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension should be taken at the start of a meal.
2.4Recommended Dosage of Amoxicillin and Clavulanate Potassium for Oral Suspension in Pediatric Patients Aged 3 Months and Older and Weighing Less Than 40 kg The recommended dosage of amoxicillin and clavulanate potassium for oral suspension for pediatric patients aged 3 months and older and weighing less than 40 kg are provided in Table 2. Amoxicillin and clavulanate potassium for oral suspension may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium for oral suspension are administered at the start of a meal.
To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension should be taken at the start of a meal. Table 2: Recommended Dosage of Amoxicillin and Clavulanate Potassium for Oral Suspension in Pediatric Patients Aged 3 Months and Older and Weighing Less Than 40 kg a The every 12 hours regimen is recommended as it is associated with les…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 125 mg/31.25 mg per 5 mL : White to off-white granular powder – Each 5 mL of reconstituted white to pale yellow, orange flavored suspension contains 125 mg of amoxicillin (as amoxicillin trihydrate) and 31.25 mg of clavulanic acid as the potassium salt. 250 mg/62.5 mg per 5 mL: White to off-white granular powder – Each 5 mL of reconstituted white to pale yellow, orange flavored suspension contains 250 mg of amoxicillin (as amoxicillin trihydrate) and 62.5 mg of clavulanic acid as the potassium salt.
For Oral Suspension: 125 mg/31.25 mg per 5 mL and 250 mg/62.5 mg per 5 mL ( 3 )
⛔ Contraindications ▾
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 and cephalosporins). ( 4.1 ) History of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium. ( 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/clavulanate potassium.
⚠️ Warnings and Cautions ▾
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) : Discontinue if DIES occurs and institute appropriate therapy. ( 5.3 ) Hepatic dysfunction and cholestatic jaundice: Discontinue if signs/symptoms of hepatitis occur. Monitor liver function tests in patients with hepatic impairment.
( 5.4 ) Clostridioides difficile -associated diarrhea (CDAD): Evaluate patients if diarrhea occurs. ( 5.5 ) Patients with mononucleosis: Increased risk of skin rash. Avoid amoxicillin and clavulanate potassium 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. 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 concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens.
Amoxicillin and clavulanate potassium is contraindicated in patients with a history of serious hypersensitivity reactions to amoxicillin, clavulanate, or to other beta-lactam antibacterial drugs [see Contraindications (4.1) ] . If an allergic reaction occurs, discontinue amoxicillin and clavulanate potassium and institute appropriate therapy.
5.2Severe Cutaneous Adverse Reactions (SCAR) Amoxicillin and clavulanate potassium may cause severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If patients develop a skin rash, they should be monitored closely, and amoxicillin and clavulanate potassium discontinued if lesions progress.
5.3Drug-Induced Enterocolitis Syndrome (DIES) Drug-induced enterocolitis syndrome (DIES) has been reported with use of amoxicillin, a component of amoxicillin and clavulanate potassium for oral suspension [see Adverse Reactions (6.2) ] , with most cases occurring in pediatric patients . DIES is a non-IgE mediated hypersensitivity reaction characterized by protracted vomiting occurring 1 to 4 hours after drug ingestion in the absence of skin or respiratory symptoms. DIES may be associated with pallor, lethargy, hypotension, shock, diarrhea within 24 hours after ingesting amoxicillin, and leukocytosis with neutrophilia.
If DIES occurs, discontinue amoxicillin and clavulanate potassium and institute appropriate therapy.
5.4Hepatic Dysfunction Hepatic dysfunction, including hepatitis and cholestatic jaundice has been associated with the use of amoxicillin and clavulanate potassium. Hepatotoxicity is usually reversible; however, deaths have been reported. These cases have generally been associated with serious underlying diseases or concomitant medications.
Amoxicillin and clavulanate potassium is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with treatment with amoxicillin and clavulanate potassium [see Contraindications (4.2) , Use in Specific Populations (8.7), 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, 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…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Allergic Reactions, including Anaphylaxis [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) ] Skin Rash in Patients with Mononucleosis [see Warnings and Precautions (5.6) ] The most frequently reported adverse reactions with amoxicillin and clavulanate potassium for oral suspension were (incidence ≥3%) diarrhea/loose stools, nausea, skin rash, and urticaria.
( 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 .
6.1Clinical 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. Amoxicillin and Clavulanate Potassium for Oral Suspension The most frequently reported adverse reactions in clinical trials were diarrhea/loose stools (9%), nausea (3%), skin rash and urticaria (3%), vomiting (1%) and vaginitis (1%).
Less than 3% of patients discontinued therapy due to adverse reactions. The overall incidence of adverse reactions, particularly diarrhea, increased with higher recommended doses. Other less frequently reported adverse reactions (<1%) included abdominal discomfort, flatulence, and headache.
In two pivotal trials in adults with lower respiratory tract or urinary tract infections , the overall incidence of adverse reactions was similar between AUGMENTIN 875 mg/125 mg Tablets every 12 hours and AUGMENTIN 500 mg/125 mg Tablets every 8 hours [see Clinical Studies (14.1 , 14.2) ] . The most common adverse reaction was diarrhea, reported in 15% of patients receiving AUGMENTIN 875 mg/125 mg every 12 hours and 14% of patients receiving AUGMENTIN 500 mg/125 mg every 8 hours. The rate of severe diarrhea or discontinuation due to diarrhea was 1% versus 2%, respectively.
In a controlled clinical trial of pediatric patients aged 2 months to 12 years with acute otitis media [see Clinical Studies (14.5) ], diarrhea was defined in the protocol as ≥3 watery stools or ≥4 loose/watery stools in 1 day, or ≥2 watery stools or ≥3 loose/watery stools per day for 2 consecutive days, as recorded on diary cards. The incidence of diarrhea was significantly lower in patients treated with amoxicillin and clavulanate potassium for oral suspension 45 mg/kg/day divided every 12 hours (14%) compared to patients treated with amoxicillin and clavulanate potassium for oral suspension 40 mg/kg/day divided every 8 hours (34%).
It is not known whether the statistically significant reduction in diarrhea with the oral suspension dosed every 12 hours, versus suspensions dosed every 8 hours, can be extrapolated to the chewable tablets, all of which contain mannitol . The presence of mannitol in the chewable tablets may contribute to a different diarrhea profile. Severe diarrhea or discontinuation due to diarrhea occurred in 3% and 8% of patients, respectively.
Allergic reactions leading to discontinuation occurred in 1% and <1% of patients, and candidal infection of the diaper area was reported in 4% and 6% of patients, respectively.
6.2Postmarketing Experience The following adverse reactions have been identified during postmarketing use of amoxicillin and clavulanate potassium product. Because these reactions are reported voluntarily from a population of uncertain 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…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Concomitant use with probenecid is not recommended. ( 7.1 ) Concomitant use with oral anticoagulants may increase the prolongation of prothrombin time. ( 7.2 ) Concomitant use with allopurinol increases the risk of rash. ( 7.3 )
7.1Probenecid Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with amoxicillin and clavulanate potassium 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. Discontinue allopurinol at the first appearance of skin rash when used concomitantly with amoxicillin and clavulanate potassium.
7.4Interference of Amoxicillin and Clavulanate Potassium with Glucose Test 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. Therefore, it is recommended that glucose tests based on enzymatic glucose oxidase reactions be used.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Renal Impairment: Dosage adjustment is recommended for severe renal impairment (GFR <30 mL/min). ( 2.6 , 8.6 )
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 conducted in pregnant rats, given doses greater than or equal to 4 and 10 times the Maximum Recommended Human Dose (MRHD) of amoxicillin trihydrate and clavulanate respectively in amoxicillin and clavulanate potassium based on body surface area, revealed no evidence of fetal harm (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 clavulanate (n=1,212), amoxicillin and clavulanate plus 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 In an embryofetal developmental study in pregnant rats, amoxicillin and clavulanate (2:1 ratio formulation of amoxicillin:clavulanate) were administered at oral doses up to 1,200 mg/kg/day during the period of organogenesis (gestation days (GD) 6 to 15).
No evidence of fetal harm was observed. Based on body surface area comparisons, the dose corresponds to approximately 4 times the MRHD for amoxicillin trihydrate and 10 times the MRHD for clavulanate potassium. In a pre-and postnatal developmental study in pregnant rats, amoxicillin and clavulanate (2:1ratio formulation of amoxicillin:clavulanate) were administered at oral doses up to 1,200 mg/kg/day beginning from GD 15 through Day 21 of lactation.
No effects on maternal reproductive function or on developmental and reproductive parameters of the offspring were observed up to the highest dose, corresponding to approximately 4 times the MRHD for amoxicillin trihydrate and 10 times the MRHD for clavulanate potassium, based on body surface area comparisons.
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 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 and any potential adverse effects on the breastfed child from amoxicillin and clavulanate potassium or from the underlying maternal condition.
8.4Pediatric Use The five amoxicillin and clavulanate potassium dosage forms (tablets, chewable tablets, oral suspension, XR tablets, an…
🤰 Pregnancy ▾
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 conducted in pregnant rats, given doses greater than or equal to 4 and 10 times the Maximum Recommended Human Dose (MRHD) of amoxicillin trihydrate and clavulanate respectively in amoxicillin and clavulanate potassium based on body surface area, revealed no evidence of fetal harm (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 clavulanate (n=1,212), amoxicillin and clavulanate plus 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 In an embryofetal developmental study in pregnant rats, amoxicillin and clavulanate (2:1 ratio formulation of amoxicillin:clavulanate) were administered at oral doses up to 1,200 mg/kg/day during the period of organogenesis (gestation days (GD) 6 to 15).
No evidence of fetal harm was observed. Based on body surface area comparisons, the dose corresponds to approximately 4 times the MRHD for amoxicillin trihydrate and 10 times the MRHD for clavulanate potassium. In a pre-and postnatal developmental study in pregnant rats, amoxicillin and clavulanate (2:1ratio formulation of amoxicillin:clavulanate) were administered at oral doses up to 1,200 mg/kg/day beginning from GD 15 through Day 21 of lactation.
No effects on maternal reproductive function or on developmental and reproductive parameters of the offspring were observed up to the highest dose, corresponding to approximately 4 times the MRHD for amoxicillin trihydrate and 10 times the MRHD for clavulanate potassium, based on body surface area comparisons.
🧒 Pediatric Use ▾
8.4Pediatric Use The five amoxicillin and clavulanate potassium dosage forms (tablets, chewable tablets, oral suspension, XR tablets, and ES-600 for oral suspension) are different products. They are approved for different pediatric indications, age groups, and weights; have different dosing regimens; and have different preparation and administration instructions. Therefore, select the recommended dosage form based on the pediatric indication, age group, and weight [see Dosage and Administration (2) ].
Lower Respiratory Tract Infections The safety and effectiveness of amoxicillin and clavulanate potassium have been established for the treatment of lower respiratory tract infections due to confirmed or suspected beta- lactamase producing isolates of Haemophilus influenzae and Moraxella catarrhalis as follows [see Indications and Usage (1.1) , Clinical Pharmacology (12.3) , Clinical Studies (14.1) ]: Amoxicillin and Clavulanate Potassium for Oral Suspension: pediatric patients weighing less than 40 kg, and in pediatric patients who cannot swallow tablets.
Effectiveness is supported by adequate and well-controlled studies in adults, with pediatric pharmacokinetic data bridging to the less than 40 kg population. Acute Bacterial Sinusitis The safety and effectiveness of amoxicillin and clavulanate potassium for oral suspension have been established for the treatment of acute bacterial sinusitis due to confirmed or suspected beta-lactamase-producing Haemophilus influenzae and Moraxella catarrhalis as follows [see Indications and Usage (1.3) , Clinical Pharmacology (12.3) , Clinical Studies (14.4) ] : Amoxicillin and Clavulanate Potassium for Oral Suspension: pediatric patients weighing less than 40 kg, and in pediatric patients who cannot swallow tablets.
Effectiveness is supported by adequate and well-controlled studies in adults, with pediatric pharmacokinetic data bridging to the less than 40 kg population. Acute Bacterial Otitis Media The safety and effectiveness of amoxicillin and clavulanate potassium have been established for the treatment of acute bacterial otitis media due to confirmed or suspected beta-lactamase-producing Haemophilus influenzae and Moraxella catarrhalis as follows [see Indications and Usage (1.4) , Clinical Pharmacology (12.3) , Clinical Studies (14.5) ] : Amoxicillin and Clavulanate Potassium for Oral Suspension: pediatric patients weighing less than 40 kg, and in pediatric patients who cannot swallow tablets.
Effectiveness is supported by adequate and well-controlled studies conducted in adults, with additional data from a study conducted in pediatric patients with acute bacterial otitis media aged 2 months to 12 years. Skin and Skin Structure Infections The safety and effectiveness of amoxicillin and clavulanate potassium have been established for the treatment of skin and skin structure infections due to confirmed or suspected beta-lactamase-producing S. aureus , Escherichia coli , and Klebsiella species as follows [see Indications and Usage (1.6) , Clinical Pharmacology (12.3) ]: Amoxicillin and Clavulanate Potassium for Oral Suspension: pediatric patients weighing less than 40 kg, and in pediatric patients who cannot swallow tablets.
Effectiveness is supported by adequate and well-controlled studies conducted in pediatric patients. Urinary Tract Infections The safety and effectiveness of amoxicillin and clavulanate potassium have been established for the treatment of urinary tract infections due to confirmed or suspected beta-lactamase-producing E. coli , Klebsiella species, and Enterobacter species as follows [see Indications and Usage (1.7) , Clinical Pharmacology (12.3) , Clinical Studies (14.2) ]: Amoxicillin and Clavulanate Potassium for Oral Suspension: pediatric patients weighing less than 40 kg, and in pediatric patients who cannot swallow tablets.
Effectiveness is supported by adequate and well-controlled studies conducted in pediatric patients. Use Not Established in Certain Pediatric Popul…
🧓 Geriatric Use ▾
8.5Geriatric Use Amoxicillin and clavulanate potassium is substantially excreted by the kidney, and the risk of adverse reactions to amoxicillin and clavulanate potassium may be greater in patients with renal impairment than in patients with normal renal function. Because geriatric patients are more likely to have renal impairment, monitor for adverse reactions. Dosage adjustment is recommended in patients with severe renal impairment [see Dosage and Administration (2.6) , Use in Specific Populations (8.6) ] .
🆘 Overdosage ▾
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, 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 and do not require gastric emptying. 1 Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations. 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 .
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Amoxicillin and clavulanate potassium is an antibacterial drug [see Clinical Pharmacology (12.4) ].
12.2Pharmacodynamics The antibacterial activity of amoxicillin/clavulanate is primarily driven by the percentage of the dosing interval during which unbound (free) amoxicillin plasma concentrations exceed the minimum inhibitory concentration (% f T>MIC) of the target bacterial organism. Clavulanate inhibits β-lactamase enzymes and thereby restores activity of amoxicillin against certain β-lactamase–producing bacteria.
12.3Pharmacokinetics Absorption Amoxicillin and Clavulanate Potassium for Oral Suspension 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.
Amoxicillin and Clavulanate Potassium for Oral Suspension and Chewable Tablets Mean pharmacokinetic parameters in healthy adult subjects following administration of Amoxicillin and Clavulanate Potassium for Oral Suspension and Chewable Tablets are shown in Table 8. Table 8: Mean (±S.D.) Amoxicillin and Clavulanate Potassium Pharmacokinetic Parameters a,b with Amoxicillin and Clavulanate Potassium for Oral Suspension and Chewable Tablets Dose of Amoxicillin and Clavulanate Potassium C max (mcg/mL) AUC 0-24 (mcg*h/mL) Amoxicillin and Clavulanate potassium Amoxicillin Clavulanate potassium Amoxicillin Clavulanate potassium 400 mg/57 mg (5 mL of suspension) 6.94 ± 1.24 1.1 ± 0.42 17.29 ± 2.28 2.34 ± 0.94 400 mg/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 healthy adult subjects.
Peak concentrations occurred~1 hour post-dose. b Administered at the start of a light meal. Administration of 5 mL of amoxicillin and clavulanate potassium oral suspension 250 mg/62.5 mg or the equivalent dose of 10 mL of amoxicillin and clavulanate potassium oral suspension 125 mg/31.25 mg results in: Mean C max (mcg/mL): amoxicillin 6.9; clavulanate 1.6 (mean peak ~1 hour post-dose) AUC during first 4 hours (mcg•h/mL): amoxicillin 12.6; clavulanate
2.9One 250 mg/62.5 mg AUGMENTIN Chewable Tablet (or two 125 mg/31.25 mg AUGMENTIN Chewable Tablets) provides an equivalent dose to 5 mL of the Amoxicillin and Clavulanate Potassium Oral Suspension 250 mg/62.5 mg, yielding similar serum concentrations of amoxicillin and clavulanic acid. Distribution The protein binding of amoxicillin and clavulanic acid to human serum is approximately 18% and 25%, respectively. Amoxicillin diffuses readily into most body tissues and fluids, with the exception of the brain and spinal fluid.
Metabolism and Excretion The half‑life of amoxicillin after the oral administration of amoxicillin and clavulanate potassium is approximately 1.3 hours and that of clavulanic acid is approximately 1 hour. Amoxicillin and Clavulanate Potassium for Oral Suspension Following administration of a single 250 mg/125 mg or 500 mg/125 mg tablet, approximately 50 to 70% of amoxicillin and approximately 25 to 40% of clavulanic acid are excreted unchanged in urine during the first 6 hours. Specific Populations: Pediatric Patients: Amoxicillin and Clavulanate Potassium for Oral Suspension Two hours after administration of a single 35 mg/kg oral dose of amoxicillin and clavulanate potassium suspension to fasting pediatrics, mean concentrations of 3 mcg/mL of amoxicillin and 0.5 mcg/mL of clavulanic acid were detected in middle ear effusions.
Drug Interaction Studies Clinical Studies Concurrent administration of probenecid delays amoxicillin excretion but does not delay renal excretion of clavulanic acid [see Drug Interactions (7.1)…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Amoxicillin and clavulanate potassium is an antibacterial drug [see Clinical Pharmacology (12.4) ].
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 125 mg/31.25 mg per 5 mL is a white to off-white granular powder – Each 5 mL of reconstituted white to pale yellow, orange flavored suspension contains 125 mg of amoxicillin as the trihydrate and 31.25 mg of clavulanic acid as the potassium salt (equivalent to 37.23 mg of clavulanate potassium). Bottles of 75 mL NDC 59651-025-75 Bottles of 100 mL NDC 59651-025-01 Bottles of 150 mL NDC 59651-025-55 Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 250 mg/62.5 mg per 5 mL is a white to off-white granular powder – Each 5 mL of reconstituted white to pale yellow, orange flavored suspension contains 250 mg of amoxicillin as the trihydrate and 62.5 mg of clavulanic acid as the potassium salt (equivalent to 74.5 mg of clavulanate potassium).
Bottles of 75 mL NDC 59651-026-75 Bottles of 100 mL NDC 59651-026-01 Bottles of 150 mL NDC 59651-026-55 Storage Powder for Oral Suspension Store dry powder at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Reconstituted Oral Suspension Store reconstituted amoxicillin and clavulanate potassium for oral suspension in the original container under refrigeration. Discard unused reconstituted suspension after 10 days. A slight color change during storage is normal. [see Dosage and Administration (2.7) ] .
📋 Description ▾
11 DESCRIPTION Amoxicillin and clavulanate potassium for oral suspension, USP is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). In amoxicillin and clavulanate potassium for oral suspension, USP, amoxicillin is present as amoxicillin trihydrate. Amoxicillin USP is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid.
Amoxicillin trihydrate has a molecular formula of C 16 H 19 N 3 O 5 S•3H 2 O, and a molecular weight of 419.46. Chemically, it is (2 S, 5 R, 6 R )-6-[( R )-(-)-2-Amino-2-( p- hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as: Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus . It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate 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. Clavulanate potassium has a molecular formula of C 8 H 8 KNO 5 and a molecular weight of 237.25. Chemically, clavulanate potassium is potassium ( Z )-( 2R,5R )-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as: 125 mg/31.25 mg: Following constitution, each 5 mL of oral suspension contains 125 mg of amoxicillin (equivalent to 143 mg of amoxicillin trihydrate) and 31.25 mg of clavulanic acid (equivalent to 37.23 mg of clavulanate potassium).
250 mg/62.5 mg: Following constitution, each 5 mL of oral suspension contains 250 mg of amoxicillin (equivalent to 287 mg of amoxicillin trihydrate) and 62.5 mg of clavulanic acid (equivalent to 74.5 mg of clavulanate potassium). Amoxicillin and clavulanate potassium for oral suspension, USP is white to off-white granular powder and becomes white to pale yellow with orange flavored suspension after reconstitution. Each 5 mL of reconstituted 125 mg/31.25 mg oral suspension of amoxicillin and clavulanate contains 7 mg potassium.
Each 5 mL of reconstituted 250 mg/62.5 mg oral suspension of amoxicillin and clavulanate contains 13 mg potassium. Inactive Ingredients: Aspartame, colloidal silicon dioxide, hypromellose, orange flavor, silicon dioxide, succinic acid, and xanthan gum [see Warnings and Precautions (5.8) ]. The orange flavor contains corn syrup, gum arabic and natural & artificial flavor.
Chemical Structure 1 Chemical Structure2
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Administration Instructions Advise patients or caregivers that when dosing a child with amoxicillin and clavulanate potassium for oral suspension, they should use a dosing spoon or medicine dropper. Be sure to rinse the spoon or dropper after each use [see Dosage and Administration (2.7) ]. Allergic Reactions Counsel patients that amoxicillin and clavulanate potassium 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 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, 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. If diarrhea develops and is severe or lasts more than 2 or 3 days, advise the patients to call their doctor [see Warnings and Precautions (5.5) ] .
Risks in Patients with Phenylketonuria Counsel patients with phenylketonuria that certain amoxicillin and clavulanate potassium for oral suspension contain aspartame, a source of phenylalanine [see Warnings and Precautions (5.8) ]: Amoxicillin and clavulanate potassium 125 mg/31.25 mg and 250 mg/62.5 mg for oral suspension contain aspartame. Each 5 mL of the 125 mg/31.25 mg per 5 mL oral suspension contains 3.16 mg phenylalanine and each 5 mL of the 250 mg/62.5 mg per 5 mL oral suspension contains 6.31 mg phenylalanine.
Antibacterial Resistance Patients should be counseled that antibacterial drugs, including amoxicillin and clavulanate potassium, 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 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 or other antibacterial drugs in the future [see Warnings and Precautions (5.9) ]. Storage Instructions Advise patients to keep amoxicillin and clavulanate potassium for oral suspension refrigerated and to shake well before using. Bottles of amoxicillin and clavulanate potassium for oral suspension may contain more liquid than required.
Advise patients to follow their doctor’s instructions about the amount to use and the days of treatment required. Discard any unused medicine [see Dosage and Administration (2.3 , 2.4 , 2.7) , How Supplied/Storage and Handling (16) ]. The brands listed are the trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited.
Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 08/2026