Amoxicillin and Clavulanate Potassium (Page 7 of 7)

15 REFERENCES

1. Swanson-Biearman B, Dean BS, Lopez G, Krenzelok EP. The effects of penicillin and cephalosporin ingestions in children less than six years of age. Vet Hum Toxicol. 1988; 30: 66-67.
   

16 HOW SUPPLIED/STORAGE AND HANDLING

875 mg/125 mg: White, capsule-shaped, biconvex, film-coated, scored tablets, debossed 93 on one side and 22 score line 75 on the other side. Each tablet contains 875 mg amoxicillin, USP as the trihydrate and 125 mg clavulanic acid as the potassium salt. They are available in (NDC 68071-2502-2) bottles of 2 , (NDC 68071-2502-3 ) bottles of 3 and (NDC 68071-2502-4) bottles of 4.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Advise patients to keep in a closed container.

17 PATIENT COUNSELING INFORMATION

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AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin and clavulanate potassium tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-2502(NDC:0093-2275) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMOXICILLIN (AMOXICILLIN ANHYDROUS) AMOXICILLIN ANHYDROUS 875 mg CLAVULANATE POTASSIUM (CLAVULANIC ACID) CLAVULANIC ACID 125 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE HYPROMELLOSE 2910 (3 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) HYPROMELLOSE 2910 (50 MPA.S) MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYDEXTROSE POLYETHYLENE GLYCOL 8000 SODIUM STARCH GLYCOLATE TYPE A POTATO TITANIUM DIOXIDE TRIACETIN

Product Characteristics Color white Score 2 pieces Shape OVAL (capsule-shaped) Size 22mm Flavor Imprint Code 93;22;75 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68071-2502-4 4 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:68071-2502-2 2 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:68071-2502-3 3 TABLET, FILM COATED in 1 BOTTLE None

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Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065096 10/31/2002

Revised: 08/2022 NuCare Pharmaceuticals,Inc.