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

PDP
(click image for full-size original)

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
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065096 10/31/2002
Labeler — NuCare Pharmaceuticals,Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals,Inc. 010632300 repack (68071-2502)

Revised: 08/2022 NuCare Pharmaceuticals,Inc.

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