AUGMENTIN ES-600 (Page 7 of 7)

REFERENCES

1. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing – 21st Informational Supplement. CSLI Document M100-S21. CLSI, 940 West Valley Rd., Suite 1400, Wayne, PA 19087, 2011.
2. Clinical and Laboratory Standards Institute (CLSI). Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria – Approved Standard 7th ed. CSLI Document M11-A7. CLSI, 940 West Valley Rd., Suite 1400, Wayne, PA 19087, 2007.
3. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard – 8th ed. CLSI Document M07-A8. CLSI, 940 West Valley Rd., Suite 1400, Wayne, PA 19087, 2009.
4. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Susceptibility Test; Approved Standard – 10th ed. CLSI Document M02-A10. CLSI, 940 West Valley Rd., Suite 1400, Wayne, PA 19087, 2009.
5. 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.

AUGMENTIN ES-600 is a registered trademark of GlaxoSmithKline and is licensed

to Dr. Reddy’s Laboratories Inc.

CLINITEST is a registered trademark of Miles, Inc.

CLINISTIX is a registered trademark of Bayer Corporation.

AUGMENTIN XR is a registered trademark of GlaxoSmithKline and is licensed to

Dr. Reddy’s Laboratories Inc.

FLAVORx is a trademark of FLAVORx. Inc.

Dist.by: Dr. Reddy’s Laboratories Inc.,

Bridgewater, NJ 08807

Principal Display Panel

NDC 43598-003-51

600 mg/42.9 mg per 5 mL

AUGMENTIN ES-600

powder for oral suspension

When reconstituted, each 5 mL contains:

AMOXICILLIN, 600 MG,

as the trihydrate

CLAVULANIC ACID, 42.9 MG,

as clavulanate potassium

75 mL (when reconstituted)

R_x only

Directions for mixing:

1. Tap bottle until all powder flows freely. ADD 70 mL OF WATER IN TWO PARTS.
2. Add approximately 2/3 of the water for reconstitution. Shake vigorously. 3. Add remaining water; shake vigorously.

Dosage: Administer every 12 hours. See accompanying prescribing information.

Phenylketonurics: Contains phenylalanine 7 mg per 5 mL.

Keep tightly closed.

Shake well before using.

Must be refrigerated.

Discard after 10 days.

Use only if inner seal is intact.

Net contents: Equivalent to 9 g amoxicillin and 0.643 g clavulanic acid.

Store dry powder at or below 25^o C (77^o F).

Dist. by: Dr. Reddy’s Laboratories Inc.,

Bridgewater, NJ 08807

I0112

150043238

AUGMENTIN ES-600 amoxicillin and clavulanate potassium powder, for suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-003 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMOXICILLIN (AMOXICILLIN ANHYDROUS) AMOXICILLIN ANHYDROUS 600 mg in 5 mL CLAVULANATE POTASSIUM (CLAVULANIC ACID) CLAVULANIC ACID 42.9 mg in 5 mL

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE XANTHAN GUM ASPARTAME CARBOXYMETHYLCELLULOSE SODIUM

Product Characteristics Color Score Shape Size Flavor STRAWBERRY Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43598-003-51 75 mL in 1 BOTTLE None 2 NDC:43598-003-69 125 mL in 1 BOTTLE None 3 NDC:43598-003-54 200 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA050755 10/31/2012

Labeler — Dr Reddys Laboratories Inc (802315887)

Registrant — Dr. Reddy’s Laboratories Inc DBA Dr. Reddy’s Laboratories Tennessee LLC (967940441)

Establishment
Name	Address	ID/FEI	Operations
Dr. Reddy’s Laboratories Inc DBA Dr. Reddy’s Laboratories Tennessee LLC		967940441	manufacture (43598-003), analysis (43598-003)

Establishment
Name	Address	ID/FEI	Operations
Beecham Pharmaceuticals (PTE) Limited		595132580	api manufacture (43598-003), analysis (43598-003)

Establishment
Name	Address	ID/FEI	Operations
SmithKline Beecham Limited		214482031	api manufacture (43598-003), analysis (43598-003)

Revised: 12/2012 Dr Reddys Laboratories Inc