Drug Safety-related Labeling Changes (SrLC)

Get Email Alerts | Guide

AUGMENTIN '250' (NDA-050597)

(AMOXICILLIN; CLAVULANATE POTASSIUM)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

Download Data

Expand all

07/17/2026 (SUPPL-53)

Approved Drug Label (PDF)

4 Contraindications

4.2 Cholestatic Jaundice/Hepatic Dysfunction

Additions and/or revisions underlined:

AUGMENTIN is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with treatment with amoxicillin/clavulanate potassium.

5 Warnings and Precautions

5.1 Serious Allergic Reactions, including Anaphylaxis

Subsection title revised

Additions and/or revisions underlined:

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 AUGMENTIN, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. AUGMENTIN 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 AUGMENTIN and institute appropriate therapy.

5.4 Hepatic Dysfunction

Additions and/or revisions underlined:

Hepatic dysfunction, including hepatitis and cholestatic jaundice has been associated with the use of AUGMENTIN. Hepatotoxicity is usually reversible; however, deaths have been reported. These cases have generally been associated with serious underlying diseases or concomitant medications. AUGMENTIN 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)].

5.5 Clostridioides difficile-Associated Diarrhea (CDAD)

Additions and/or revisions underlined:

. . .

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

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

5.6 Skin Rash in Patients with Mononucleosis

Additions and/or revisions underlined:

A high percentage of patients with mononucleosis who receive amoxicillin develop an erythematous skin rash. Avoid AUGMENTIN use in patients with mononucleosis [see Adverse Reactions (6.2)].

5.7 Potential for Microbial Overgrowth

Additions and/or revisions underlined:

The possibility of superinfections with mycotic or bacterial pathogens should be considered during therapy. If superinfections occur (commonly involving Pseudomonas spp. or Candida spp.), discontinue AUGMENTIN and institute appropriate therapy.

5.8 Risks in Patients with Phenylketonuria

Subsection title revised

Additions and/or revisions underlined:

Phenylalanine can be harmful to patients with phenylketonuria (PKU). Certain formulations of AUGMENTIN contain aspartame, which is a source of phenylalanine: 200 mg Chewable Tablets (2.1 mg phenylalanine per tablet); 400 mg Chewable Tablets (4.2 mg phenylalanine per tablet); 200 mg/5 mL and 400 mg/5 mL AUGMENTIN for Oral Suspension and AUGMENTIN ES-600 for Oral Suspension (7 mg phenylalanineper 5 mL). Before prescribing these AUGMENTIN formulations to patients with PKU, consider the combined daily amount of phenylalanine from all sources, including AUGMENTIN.

Other formulations, including the 125 mg/31.25 mg and 250 mg/62.5 mg Chewable Tablets and the corresponding for Oral Suspension (125 mg/31.25 mg per 5 mL and 250 mg/62.5 mg per 5 mL), do not contain aspartame.

6 Adverse Reactions

Additions and/or revisions underlined:

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)]

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

. . .

AUGMENTIN Tablets, AUGMENTIN Chewable Tablets, and AUGMENTIN 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 greater than or equal to 3 watery stools or greater than or equal to 4 loose/watery stools in 1 day, or greater than or equal to 2 watery stools or greater than or equal to 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 AUGMENTIN for Oral Suspension 45 mg/kg/day divided every 12 hours (14%) compared to patients treated with AUGMENTIN 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 [see Description (11)]. 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.

AUGMENTIN XR Extended-Release Tablets

In clinical trials, 5,643 patients have been treated with AUGMENTIN XR Extended-Release Tablets. The most frequently reported adverse reactions were diarrhea (15%), vaginal mycosis (3%), nausea (2%), and loose stools (2%). AUGMENTIN XR Extended-Release Tablets were associated with a higher rate of diarrhea requiring corrective therapy (4% versus 3% for AUGMENTIN XR Extended-Release Tablets and all comparators, respectively). Two percent of patients discontinued therapy due to adverse reactions.

AUGMENTIN ES-600 for Oral Suspension

Two clinical trials evaluated the safety of a 10-day treatment course of AUGMENTIN ES-600 for Oral Suspension 90/6.4 mg/kg/day, divided every 12 hours, in pediatric patients with recurrent or persistent acute otitis media [see Clinical Studies (14.6)]. The first trial involved 521 pediatric patients (aged 3 months to 50 months), and the second trial involved 450 pediatric patients (aged 3 months to 12 years).

In the first trial, the most frequently reported adverse reactions were vomiting (7%), fever (6%), contact dermatitis (i.e., diaper rash) (6%), upper respiratory tract infection (4%), and diarrhea (4%). Diarrhea, defined in the protocol as greater than or equal to 3 watery stools in one day or greater than or equal to 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 AUGMENTIN ES-600 for Oral Suspension at 90/6.4 mg/kg/day, divided every 12 hours to AUGMENTIN for Oral Suspension at 45/6.4 mg/kg/day, divided every 12 hours for ten days. Adverse reactions were similar between treatment groups. The most frequently reported adverse reactions for AUGMENTIN ES-600 for Oral Suspension and the comparator 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. Protocol-defined diarrhea occurred in 11% of patients receiving AUGMENTIN ES-600 for Oral Suspension and 9% of patients receiving the comparator; the difference was not statistically different. Two patients in the AUGMENTIN ES-600 for Oral Suspension group and one patient in the comparator group discontinued treatment due to diarrhea.

6.2 Postmarketing Experience

Additions and/or revisions underlined:

The following adverse reactions have been identified during postmarketing use of AUGMENTIN products. 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), 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)].

. . .

Liver: A moderate rise in AST (SGOT) and/or ALT (SGPT) has been noted in patients treated with ampicillin-class antibacterials. Hepatic dysfunction, including increases in serum transaminases (AST and/or ALT), serum bilirubin, and/or alkaline phosphatase, has been reported with AUGMENTIN. It has been reported more commonly in the elderly, in males, or in patients on prolonged treatment. The histologic findings on liver biopsy have consisted of cholestatic, hepatocellular, or mixed cholestatic-hepatocellular changes. The onset of signs/symptoms of hepatic dysfunction may occur during or several weeks after therapy has been discontinued. The hepatic dysfunction, which may be severe, is usually reversible. Deaths have been reported [see Contraindications (4.2), Warnings and Precautions (5.4)].

Renal: Interstitial nephritis and hematuria have been reported. Crystalluria has also been reported [see Overdosage (10)].

Hemic and Lymphatic Systems: Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. There have been reports of increased prothrombin time in patients receiving AUGMENTIN and anticoagulant therapy concomitantly [see Drug Interactions (7.2)].

. . .

7 Drug Interactions

7.1 Probenecid

Additions and/or revisions underlined:

Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with AUGMENTIN may result in increased and prolonged blood levels of amoxicillin. Co-administration of probenecid is not recommended.

7.3 Allopurinol

Additions and/or revisions underlined:

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 AUGMENTIN.

7.4 Interference of AUGMENTIN with Glucose Test

Subsection title revised

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.

8 Use in Specific Populations

8.1 Pregnancy

PLLR Conversion

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 AUGMENTIN 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) 6-15). 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 (2:1 ratio 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.

8.2 Lactation

PLLR Conversion

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 AUGMENTIN 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 AUGMENTIN and any potential adverse effects on the breastfed child from AUGMENTIN or from the underlying maternal condition.

8.3 Pediatric Use

Extensive changes; please refer to label for complete information.

8.4 Geriatric Use

Additions and/or revisions underlined:

Of the 3,119 patients included in clinical studies of AUGMENTIN Tablets, 32% were 65 years of age and older and 14% were 75 years of age and older. In clinical studies of AUGMENTIN XR Extended-Release Tablets, 18% of patients were 65 years of age and older and 7% were 75 years of age and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other clinical experience has not identified differences in responses between elderly and younger patients.

AUGMENTIN is substantially excreted by the kidney, and the risk of adverse reactions to AUGMENTIN 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)].

8.5 Renal Impairment

Additions and/or revisions underlined:

Amoxicillin is primarily eliminated by the kidney. Both amoxicillin and clavulanate are removed from the circulation by hemodialysis.

AUGMENTIN

No dosage adjustment is recommended in patients with mild to moderate renal impairment. A reduced dosage is recommended in patients with severe renal impairment (GFR less than 30 mL/min). Patients with a GFR of less than 30 mL/min should not receive the 875 mg/125 mg dose of AUGMENTIN [see Dosage and Administration (2.6)].

AUGMENTIN XR Extended-Release Tablets and AUGMENTIN ES-600 for Oral Suspension The pharmacokinetics of AUGMENTIN XR Extended-Release Tablets and AUGMENTIN ES-600 for Oral Suspension have not been studied in patients with renal impairment. Patients with severe renal impairment (GFR less than 30 mL/min) and patients on intermittent hemodialysis should not receive AUGMENTIN XR Extended-Release Tablets or AUGMENTIN ES-600 for Oral Suspension [see Dosage and Administration (2.6)].

8.7 Hepatic Impairment

Newly added subsection

Monitor hepatic function as appropriate during therapy with AUGMENTIN [see Contraindications (4.2), Warnings and Precautions (5.4)].

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Administration Instructions

Advise patients or caregivers that when dosing a child with AUGMENTIN 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)].

. . .

Diarrhea

Counsel patients that diarrhea is a common problem caused by antibacterial drugs, including AUGMENTIN, 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 AUGMENTIN formulations contain aspartame, a source of phenylalanine [see Warnings and Precautions (5.8)]:

• Each 5 mL of AUGMENTIN ES-600 for Oral Suspension contains 7 mg phenylalanine.
• AUGMENTIN 200 mg/28.5 mg and 400 mg/57 mg for Oral Suspension and Chewable Tablets contain aspartame. Each 200 mg chewable tablet contains 2.1 mg phenylalanine; each 400 mg chewable tablet contains 4.2 mg phenylalanine; and each 5 mL of the 200 mg/5 mL or 400 mg/5 mL oral suspension contains 7 mg phenylalanine.

Antibacterial Resistance

Patients should be counseled that antibacterial drugs, including AUGMENTIN, should only be used to treat bacterial infections. Antibacterial drugs do not treat viral infections (e.g., the common cold). When AUGMENTIN 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 AUGMENTIN or other antibacterial drugs in the future [see Warnings and Precautions (5.9)].

Storage Instructions

Advise patients to keep AUGMENTIN for oral suspension refrigerated and to shake well before using. Bottles of AUGMENTIN 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)].

05/01/2024 (SUPPL-52)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.3 Drug-Induced Enterocolitis Syndrome (DIES)

Newly added subsection:

Drug-induced enterocolitis syndrome (DIES) has been reported with use of amoxicillin, a component of AUGMENTIN [see Adverse Reactions (6.2)], with most cases occurring in pediatric patients less than or equal to 18 years of age. 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 of ingesting amoxicillin, and leukocytosis with neutrophilia. If DIES occurs, discontinue AUGMENTIN and institute appropriate therapy.

6 Adverse Reactions

Additions and revisions underlined:

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)]

6.2 Postmarketing Experience

Additions and revisions underlined:

. . .

Gastrointestinal: Drug-induced enterocolitis syndrome (DIES), 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 (5.5)].

. . .

Skin and Appendages: Rashes, pruritus, urticaria, erythema multiforme, SJS, TEN, DRESS, AGEP, exfoliative dermatitis, and linear IgA bullous dermatosis.

. . .

08/25/2022 (SUPPL-51)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Severe Cutaneous Adverse Reactions

New subsection added

AUGMENTIN 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 AUGMENTIN discontinued if lesions progress.

5.8 Development of Drug-Resistant Bacteria

Additions and/or revisions underlined

Prescribing AUGMENTIN in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug?resistant bacteria.

6 Adverse Reactions

Addition of the following to the bulleted line listing:

• Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.2)]

  6.2 Postmarketing Experience

  Additions and/or revisions underlined

  …

  Immune: Hypersensitivity reactions, anaphylactic/anaphylactoid reactions (including shock), angioedema, serum sickness-like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), hypersensitivity vasculitis [see Warnings and Precautions (5.1)].

  Skin and Appendages: Rashes, pruritus, urticaria, erythema multiforme, SJS, TEN, DRESS, AGEP, exfoliative dermatitis [see Warnings and Precautions (5.2)].

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined

…

Severe Cutaneous Adverse Reactions (SCAR)

Advise patients about the signs and symptoms of serious skin manifestations. Instruct patients to stop taking AUGMENTIN 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 antibacterials, and it usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken their last dose of the antibacterial. If diarrhea is severe or lasts more than 2 or 3 days, patients should contact their physician as soon as possible.

…

Storage Instructions

Advise patients to keep suspension refrigerated. Shake well before using. When dosing a child with the suspension (liquid) of AUGMENTIN, use a calibrated oral syringe. Be sure to rinse the calibrated oral syringe after each use. Bottles of suspension of AUGMENTIN 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.