Amoxicillin and Clavulanate Potassium (Page 6 of 6)

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.
2. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – 8 ^th ed. CLSI Document M7-A9. CLSI, 940 West Valley Road, Suite 1400, Wayne, PA, 19087, 2012.
3. Clinical and Laboratory Standards Institute (CLSI). Performance Standard for Antimicrobial Disk Susceptibility Tests; Approved Standard – 11 ^th ed. CLSI Document M2-A11. CLSI, 940 West Valley Road, Suite 1400, Wayne, PA, 19087, 2012.
4. CLSI. Performance Standards for Antimicrobial Susceptibility Testing: 22 ^nd Informational Supplement. CLSI document M100-S22. CLSI, Wayne, PA, 2012.

16 HOW SUPPLIED/STORAGE AND HANDLING

A moxicillin and Clavulanate Potassium Tablets USP, 250 mg/125 mg are white to off-white, oval shaped, film-coated tablets, debossed with ‘A’ on one side and ‘63’ on the other side.
Bottles of 30 NDC 65862-501-30
Bottles of 500 NDC 65862-501-05
10 x 10 Unit-dose Tablets NDC 65862-501-10

Amoxicillin and Clavulanate Potassium Tablets USP, 500 mg/125 mg are white to off-white, oval shaped, film-coated tablets, debossed with ‘X’ on one side and ‘33’ on the other side.
Bottles of 20 NDC 65862-502-20
Bottles of 500 NDC 65862-502-05
10 x 10 Unit-dose Tablets NDC 65862-502-10

Amoxicillin and Clavulanate Potassium Tablets USP, 875 mg/125 mg are white to off-white, capsule shaped, film-coated tablets, debossed with ‘X’ on one side and score line in between 3 and 2 on the other side.
Bottles of 20 NDC 65862-503-20
Bottles of 100 NDC 65862-503-01
10 x 10 Unit-dose Tablets NDC 65862-503-10
Dispense in a tight container [see USP].
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Keep out of the reach of children.

17 PATIENT COUNSELING INFORMATION

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17.1 Information for Patients

Patients should be informed that amoxicillin and clavulanate potassium may be taken every 8 hours or every 12 hours, depending on the dose prescribed. Each dose should be taken with a meal or snack to reduce the possibility of gastrointestinal upset.
Patients should be counseled that antibacterial drugs, including amoxicillin and clavulanate potassium, should only be used to treat bacterial infections. They 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.
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.
Patients should be aware that amoxicillin and clavulanate potassium contains a penicillin class drug product that can cause allergic reactions in some individuals.
CLINITEST is a registered trademark of Miles, Inc.
Manufactured for:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 072, India
Revised: 03/2013

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 875 mg/125 mg (20 Tablet Bottle)

Blenheim Pharmacal, Inc.
NDC 10544-931-20
Amoxicillin and Clavulanate Potassium

Tablets, USP
875 mg/125 mg
Rx only 20 Tablets

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

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10544-931(NDC:65862-503) 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 CROSPOVIDONE HYPROMELLOSE 2910 (5 MPA.S) HYPROMELLOSE 2910 (15000 MPA.S) MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 4000 POLYETHYLENE GLYCOL 6000 SODIUM STARCH GLYCOLATE TYPE A POTATO ETHYLCELLULOSES TITANIUM DIOXIDE

Product Characteristics Color white (White to Off-white) Score 2 pieces Shape CAPSULE Size 22mm Flavor Imprint Code X;3;2 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:10544-931-20 20 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:10544-931-14 14 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:10544-931-06 6 TABLET, FILM COATED in 1 BOTTLE None 4 NDC:10544-931-10 10 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091568 05/28/2015

Labeler — Blenheim Pharmacal, Inc. (171434587)

Registrant — Blenheim Pharmacal, Inc. (171434587)

Establishment
Name	Address	ID/FEI	Operations
Blenheim Pharmacal, Inc		171434587	repack (10544-931)

Revised: 04/2016 Blenheim Pharmacal, Inc.