amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral Suspension

DRUG INTERACTIONS

7 Probenicid decreases renal tubular secretion of amoxicillin which may result in increased blood levels of amoxicillin.

( 7.1 ) Concomitant use of Amoxicillin and oral anticoagulants may increase the prolongation of prothrombin time.

( 7.2 ) Coadministration 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 amoxicillin rashes is due to allopurinol or the hyperuricemia present in these patients.

7.4 Oral Contraceptives AMOXICILLIN may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.

7.5 Other Antibacterials Chloramphenicol, macrolides, sulfonamides, and tetracyclines may interfere with the bactericidal effects of penicillin.

This has been demonstrated in vitro; however, the clinical significance of this interaction is not well documented.

7.6 Effects on Laboratory Tests High urine concentrations of ampicillin 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, it is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as CLINISTIX ® ) be used.

Following administration of ampicillin or amoxicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted.

OVERDOSAGE

10 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.

Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdosage with amoxicillin1.

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 amoxicillin.

Amoxicillin may be removed from circulation by hemodialysis.

DESCRIPTION

11 Formulations of AMOXICILLIN contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms.

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.

It may be represented structurally as: The amoxicillin molecular formula is C 16 H 19 N 3 O 5 S•3H 2 O, and the molecular weight is 419.45.

Capsules: Each capsule of AMOXICILLIN, with royal blue opaque cap and pink opaque body, contains 250 mg or 500 mg amoxicillin as the trihydrate.

The cap and body of the 250-mg capsule are imprinted with the product name AMOXIL and 250; the cap and body of the 500 mg capsule are imprinted with AMOXIL and 500.

Inactive ingredients: D&C Red No.

28, FD&C Blue No.

1, FD&C Red No.

40, gelatin, magnesium stearate, and titanium dioxide.

Tablets: Each tablet contains 500 mg or 875 mg amoxicillin as the trihydrate.

Each film-coated, capsule-shaped, pink tablet is debossed with AMOXIL centered over 500 or 875, respectively.

The 875-mg tablet is scored on the reverse side.

Inactive ingredients: Colloidal silicon dioxide, crospovidone, FD&C Red No.

30 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide.

Powder for Oral Suspension: Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate.

Each 5 mL of the 125-mg reconstituted suspension contains 0.11 mEq (2.51 mg) of sodium.

Each 5 mL of the 200-mg reconstituted suspension contains 0.15 mEq (3.39 mg) of sodium.

Each 5 mL of the 250 mg reconstituted suspension contains 0.15 mEq (3.36 mg) of sodium; each 5 mL of the 400 mg reconstituted suspension contains 0.19 mEq (4.33 mg) of sodium.

Inactive ingredients: FD&C Red No.

3, flavorings, silica gel, sodium benzoate, sodium citrate, sucrose, and xanthan gum.

amoxicillin-chemstruc

CLINICAL STUDIES

14 14.1 H.

pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Randomized, double-blind clinical studies performed in the United States in patients with H.

pylori and duodenal ulcer disease (defined as an active ulcer or history of an ulcer within 1 year) evaluated the efficacy of lansoprazole in combination with amoxicillin capsules and clarithromycin tablets as triple 14 day therapy, or in combination with amoxicillin capsules as dual 14 day therapy, for the eradication of H.

pylori.

Based on the results of these studies, the safety and efficacy of 2 different eradication regimens were established: Triple therapy : Amoxicillin 1 gram twice daily/clarithromycin 500 mg twice daily/lansoprazole 30 mg twice daily (see Table 6) .

Dual therapy : Amoxicillin 1 gram three times daily/lansoprazole 30 mg three times daily (see Table 7) .

All treatments were for 14 days.

H.

pylori eradication was defined as 2 negative tests (culture and histology) at 4 to 6 weeks following the end of treatment.

Triple therapy was shown to be more effective than all possible dual therapy combinations.

Dual therapy was shown to be more effective than both monotherapies.

Eradication of H.

pylori has been shown to reduce the risk of duodenal ulcer recurrence.

Table 6.

H.

pylori Eradication Rates When Amoxicillin is Administered as Part of a Triple Therapy Regimen Study Triple Therapy Triple Therapy ​Evaluable Analysis a [95% Confidence Interval] (number of patients) Intent-to-Treat Analysis b [95% Confidence Interval] (number of patients) Study 1 92 [80.0 – 97.7] (n = 48) 86 [73.3 – 93.5] (n = 55) Study 2 86 [75.7 – 93.6] (n = 66) 83 [72.0 – 90.8] (n = 70) a This analysis was based on evaluable patients with confirmed duodenal ulcer (active or within 1 year) and H.

pylori infection at baseline defined as at least 2 of 3 positive endoscopic tests from CLOtest®, histology, and/or culture.

Patients were included in the analysis if they completed the study.

Additionally, if patients dropped out of the study due to an adverse event related to the study drug, they were included in the analysis as failures of therapy.

b Patients were included in the analysis if they had documented H.

pylori infection at baseline as defined above and had a confirmed duodenal ulcer (active or within 1 year).

All dropouts were included as failures of therapy.

Table 7.

H.

pylori Eradication Rates When Amoxicillin is Administered as Part of a Dual Therapy Regimen Study Dual Therapy Dual Therapy Evaluable Analysis a [95% Confidence Interval] (number of patients) Intent-to-Treat Analysis b [95% Confidence Interval] (number of patients) Study 1 77 [62.5 – 87.2] (n = 51) 70 [56.8 – 81.2] (n = 60) Study 2 66 [51.9 – 77.5] (n = 58) 61 [48.5 – 72.9] (n = 67) a This analysis was based on evaluable patients with confirmed duodenal ulcer (active or within 1 year) and H.

pylori infection at baseline defined as at least 2 of 3 positive endoscopic tests from CLOtest®, histology, and/or culture.

Patients were included in the analysis if they completed the study.

Additionally, if patients dropped out of the study due to an adverse event related to the study drug, they were included in the analysis as failures of therapy.

b Patients were included in the analysis if they had documented H.

pylori infection at baseline as defined above and had a confirmed duodenal ulcer (active or within 1 year).

All dropouts were included as failures of therapy.

HOW SUPPLIED

16 /STORAGE AND HANDLING Capsules: Each capsule of AMOXICILLIN, with royal blue opaque cap and pink opaque body, contains 250 mg or 500 mg amoxicillin as the trihydrate.

The cap and body of the 250-mg capsule are imprinted with the product name AMOXIL and 250; the cap and body of the 500 mg capsule are imprinted with AMOXIL and 500 250-mg Capsule NDC 43598-225-01 Bottles of 100 NDC 43598-225-05 Bottles of 500 500-mg Capsule NDC 43598-205-01 Bottles of 100 NDC 43598-205-05 Bottles of 500 Tablets: Each tablet contains 500 mg or 875 mg amoxicillin as the trihydrate.

Each film-coated, capsule-shaped, pink tablet is debossed with AMOXIL centered over 500 or 875, respectively.

The 875-mg tablet is scored on the reverse side.

500-mg Tablet NDC 43598-224-14 Bottles of 20 NDC 43598-224-01 Bottles of 100 NDC 43598-224-05 Bottles of 500 875-mg Tablet NDC 43598-219-14 Bottles of 20 NDC 43598-219-01 Bottles of 100 Powder for Oral Suspension: Each 5 mL of reconstituted strawberry-flavored suspension contains 125 mg amoxicillin as the trihydrate.

Each 5 mL of reconstituted bubble-gum-flavored suspension contains 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate.

125 mg/5 mL NDC 43598-222-80 80-mL bottle NDC 43598-222-52 100-mL bottle NDC 43598-222-53 150-mL bottle 200 mg/5 mL NDC 43598-223-50 50-mL bottle NDC 43598-223-51 75-mL bottle NDC 43598-223-52 100-mL bottle 250 mg/5 mL NDC 43598-209-80 80-mL bottle NDC 43598-209-52 100-mL bottle NDC 43598-209-53 150-mL bottle 400 mg/5 mL NDC 43598-207-50 50-mL bottle NDC 43598-207-51 75-mL bottle NDC 43598-207-52 100-mL bottle Store at or below 25ºC (77ºF) 250 mg and 500 mg Capsules 500 mg and 875 mg Tablets 200 mg and 400 mg unreconstituted powder Store Dry Powder at 20ºC-25ºC (68ºF-77ºF) 125 mg and 250 mg unreconstituted powder

RECENT MAJOR CHANGES

Indications and Usage, Gonorrhea ( 1.5 )………………………………………………………………………………

Removed 9/2015 Dosage and Administration, Gonorrhea ( 2.1 ) …………………………………………………………………………Removed 9/2015

DOSAGE FORMS AND STRENGTHS

3 Capsules: 250 mg, 500 mg.

Each capsule of AMOXICILLIN, with royal blue opaque cap and pink opaque body, contains 250 mg or 500 mg amoxicillin as the trihydrate.

The cap and body of the 250-mg capsule are imprinted with the product name AMOXIL and 250; the cap and body of the 500 mg capsule are imprinted with AMOXIL and 500.

Tablets: 500 mg, 875 mg.

Each tablet contains 500 mg or 875 mg amoxicillin as the trihydrate.

Each film-coated, capsule-shaped, pink tablet is debossed with AMOXIL centered over 500 or 875, respectively.

The 875-mg tablet is scored on the reverse side.

Powder for Oral Suspension: 125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL, 400 mg/5 mL.

Each 5 mL of reconstituted strawberry-flavored suspension contains 125 mg amoxicillin as the trihydrate.

Each 5 mL of reconstituted bubble-gum-flavored suspension contains 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate.

Capsules: 250 mg, 500 mg ( 3 ) Tablets: 500 mg, 875 mg ( 3 ) Powder for Oral Suspension: 125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL, 400 mg/5 mL ( 3 )

INDICATIONS AND USAGE

1 AMOXICILLIN is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms.

Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract.

( 1.1 – 1.4 ) In combination for treatment of H.

pylori infection and duodenal ulcer disease.

( 1.5 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of AMOXICILLIN and other antibacterial drugs, AMOXICILLIN should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.

( 1.6 ) 1.1 Infections of the Ear, Nose, and Throat AMOXICILLIN is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus species.

(α and β hemolytic isolates only), Streptococcus pneumoniae , Staphylococcus spp., or Haemophilus influenzae .

1.2 Infections of the Genitourinary Tract AMOXICILLIN is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli , Proteus mirabilis , or Enterococcus faecalis .

1.3 Infections of the Skin and Skin Structure AMOXICILLIN is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp.

(α and β hemolytic isolates only), Staphylococcus spp., or E.

coli.

1.4 Infections of the Lower Respiratory Tract AMOXICILLIN is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp.

(α and β hemolytic isolates only), S.

pneumoniae , S taphylococcus spp ., or H.

influenzae .

1.5 Helicobacter pylori Infection Triple therapy for Helicobacter pylori with clarithromycin and lansoprazole: AMOXICILLIN, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H.

pylori infection and duodenal ulcer disease (active or 1 year history of a duodenal ulcer) to eradicate H.

pylori .

Eradication of H.

pylori has been shown to reduce the risk of duodenal ulcer recurrence.

Dual therapy for H.

pylori with lansoprazole : AMOXICILLIN, in combination with lansoprazole delayed release capsules as dual therapy, is indicated for the treatment of patients with H.

pylori infection and duodenal ulcer disease (active or 1 year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected .

(See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H.

pylori has been shown to reduce the risk of duodenal ulcer recurrence.

1.6 Usage To reduce the development of drug resistant bacteria and maintain the effectiveness of AMOXICILLIN and other antibacterial drugs, AMOXICILLIN should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.

When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.

In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

WARNING AND CAUTIONS

5 WARNINGS AND PRECAUTIONS Anaphylactic reactions: Serious and occasionally fatal anaphylactic reactions have been reported in patients on penicillin therapy.

Serious anaphylactic reactions require immediate emergency treatment with supportive measures.

( 5.1 ) Clostridium difficile -associated diarrhea (ranging from mild diarrhea to fatal colitis): Evaluate if diarrhea occurs.

( 5.2 ) 5.1 Anaphylactic Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy including amoxicillin.

Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins.

These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens.

There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins.

Before initiating therapy with AMOXICILLIN, careful inquiry should be made regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens.

If an allergic reaction occurs, AMOXICILLIN should be discontinued and appropriate therapy instituted.

5.2 Clostridium difficile Associated Diarrhea Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including AMOXICILLIN, 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 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 use.

Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C.

difficile may need to be discontinued.

Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C.

difficile , and surgical evaluation should be instituted as clinically indicated.

5.3 Development of Drug-Resistant Bacteria Prescribing AMOXICILLIN in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

5.4 Use in Patients With Mononucleosis A high percentage of patients with mononucleosis who receive amoxicillin develop an erythematous skin rash.

Thus amoxicillin should not be administered to patients with mononucleosis.

5.5 Phenylketonurics Amoxicillin chewable tablets contain aspartame which contains phenylalanine.

Each 200 mg chewable tablet contains 1.82 mg phenylalanine; each 400 mg chewable tablet contains 3.64 mg phenylalanine.

The oral suspensions of Amoxicillin do not contain phenylalanine and can be used by phenylketonurics.

INFORMATION FOR PATIENTS

17 PATIENT COUNSELING INFORMATION Information for Patients Patients should be advised that AMOXICILLIN may be taken every 8 hours or every 12 hours, depending on the dose prescribed.

Patients should be counseled that antibacterial drugs, including AMOXICILLIN, should only be used to treat bacterial infections.

They do not treat viral infections (e.g., the common cold).

When AMOXICILLIN 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 or other antibacterial drugs in the future.

Patients should be counseled that diarrhea is a common problem caused by antibiotics, and it usually ends when the antibiotic is discontinued.

Sometimes after starting treatment with antibiotics, 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 antibiotic.

If this occurs, patients should contact their physician as soon as possible.

Patients should be aware that AMOXICILLIN contains a penicillin class drug product that can cause allergic reactions in some individuals.

AMOXIL is registered trademark of GlaxoSmithKline and is licensed to Dr.

Reddy’s Laboratories Inc.

Manufactured.

By: Dr.

Reddy’s Laboratories Tennessee LLC.

Bristol, TN 37620 Issued: 052016

DOSAGE AND ADMINISTRATION

2 In adults, 750-1750 mg/day in divided doses every 8-12 hours.

In Pediatric Patients > 3 Months of Age, 20-45 mg/kg/day in divided doses every 8-12 hours.

Refer to full prescribing information for specific dosing regimens.

( 2.1 , 2.2 , 2.3 ) The upper dose for neonates and infants ≤ 3 months is 30 mg/kg/day divided every 12 hours.

( 2.2 ) Dosing for H.

pylori Infection: 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.

( 2.3 ) Reduce the dose in patients with severe renal impairment (GFR <30 mL/min).

( 2.4 ) 2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age 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 infections, therapy may be required for several weeks.

It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

Table 1.

Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severity a Usual Adult Dose Usual Dose for Children > 3 Months b Ear/Nose/Throat Skin/Skin Structure Genitourinary Tract Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.

b The children’s dosage is intended for individuals whose weight is less than 40 kg.

Children weighing 40 kg or more should be dosed according to the adult recommendations.

2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months) 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.

Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of AMOXICILLIN is 30 mg/kg/day divided every 12 hours.

There are currently no dosing recommendations for pediatric patients with impaired renal function.

2.3 Dosing for H.

pylori Infection Triple therapy: The recommended adult oral dose is 1 gram AMOXICILLIN, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

Dual therapy: The recommended adult oral dose is 1 gram AMOXICILLIN and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

Please refer to clarithromycin and lansoprazole full prescribing information.

2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe.

Severely impaired patients with a glomerular filtration rate of < 30 mL/min.

should not receive a 875 mg dose.

Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection.

Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

They should receive an additional dose both during and at the end of dialysis.

2.5 Directions for Mixing Oral Suspension Tap bottle until all powder flows freely.

Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder.

Add remainder of the water and again shake vigorously.

Table 2.

Amount of Water for Mixing Oral Suspension Strength Bottle Size Amount of Water Required for Reconstitution Oral Suspension 125 mg/5 mL 80 mL 62 mL 100 mL 78 mL 150 mL 116 mL Oral Suspension 200 mg/5 mL 50 mL 39 mL 75 mL 57 mL 100 mL 76 mL Oral Suspension 250 mg/5 mL 80 mL 59 mL 100 mL 74 mL 150 mL 111 mL Oral Suspension 400 mg/5 mL 50 mL 36 mL 75 mL 54 mL 100 mL 71 mL After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing.

Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks.

These preparations should then be taken immediately.

NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING.

Keep bottle tightly closed.

Any unused portion of the reconstituted suspension must be discarded after 14 days.

Refrigeration is preferable, but not required.