Amoxicillin and Clavulanate Potassium (Page 7 of 7)

PRINCIPAL DISPLAY PANEL

Principal Display Pane

l NDC 43598-218-30

30 Tablets

AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS

AMOXICILLIN, 250 MG, as the trihydrate

CLAVULANIC ACID, 125 MG, as clavulanate potassium

Rx only

250 mg/125 mg

Store at room temperature.

Dispense in original container; advise patients to keep in closed container.

Each tablet contains 250 mg amoxicillin as the trihydrate, 125 mg clavulanic acid as clavulanate potassium.

Dosage: See accompanying prescribing information.

Use only if inner seal is intact.

Manufactured. By: Dr. Reddy’s Laboratories Tennessee LLC.Bristol, TN 37620

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PRINCIPAL DISPLAY PANEL

Principal Display Panel

NDC 43598-206-14

20 Tablets

AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS

AMOXICILLIN, 500 MG, as the trihydrate

CLAVULANIC ACID, 125 MG, as clavulanate potassium

Rx only

500 mg/125 mg

Store at or below 25°C (77°F). Dispense in original container; advise patients to keep in closed container.

Each tablet contains 500 mg amoxicillin as the trihydrate, 125 mg clavulanic acid as clavulanate potassium.

Dosage: One tablet every 12 hours. See prescribing information.

Use only if inner seal is intact.

Manufactured. By: Dr. Reddy’s Laboratories Tennessee LLC.Bristol, TN 37620

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PRINCIPAL DISPLAY PANEL

Principal Display Panel

NDC 43598-221-14

20 Tablets

AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS

AMOXICILLIN, 875 MG, as the trihydrate

CLAVULANIC ACID, 125 MG, as clavulanate potassium

Rx only

875 mg/125 mg

Store at or below 25°C (77°F). Dispense in original container; advise patients to keep in closed container.

Each tablet contains 875 mg amoxicillin as the trihydrate, 125 mg clavulanic acid as clavulanate potassium.

Dosage: One tablet every 12 hours. See prescribing information.

Use only if inner seal is intact.

Manufactured. By: Dr. Reddy’s Laboratories Tennessee LLC.Bristol, TN 37620

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PRINCIPAL DISPLAY PANEL

Principal Display Panel

NDC 43598-204-51

Amoxicillin and Clavulanate Potassium

250 mg/62.5 mg per 5 mL

AMOXICILLIN AND CLAVULANATE POTASSIUM

FOR ORAL SUSPENSION

When reconstituted, each 5 mL contains:

AMOXICILLIN, 250 MG,

as the trihydrate

CLAVULANIC ACID , 62.5 MG, as clavulanate potassium

75 mL (when reconstituted)

Rx only

Directions for mixing:

Tap bottle until all powder flows freely. Add approximately 2/3 of total water for reconstitution (total = 65 mL); shake vigorously to wet powder. Add remaining water; again shake vigorously.

Dosage: See accompanying prescribing information.

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 3.75 g amoxicillin and 0.938 g clavulanic acid.

Store dry powder at room temperature.

Manufactured. By: Dr. Reddy’s Laboratories Tennessee LLC.Bristol, TN 37620

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PRINCIPAL DISPLAY PANEL

Principal Display Panel

NDC 43598-213-50

Amoxicillin and Clavulanate Potassium

200 mg/28.5 mg per 5 mL

AMOXICILLIN/CLAVULANATE POTASSIUM

FOR ORAL SUSPENSION

When reconstituted, each 5 mL contains:

AMOXICILLIN, 200 MG,

as the trihydrate

CLAVULANIC ACID, 28.5 MG,

as clavulanate potassium

50 mL (when reconstituted)

Rx only

Directions for mixing:

Tap bottle until all powder flows freely. Add approximately 2/3 of total water for reconstitution (total = 50 mL) ; shake vigorously to wet powder. Add remaining water; again shake vigorously.

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

Keep tightly closed. Shake well before using.

Must be refrigerated. Discard after 10 days.

Phenylketonurics: Contains phenylalanine 7 mg per 5 mL.

Net contents: Equivalent to 2 g amoxicillin and 0.285 g clavulanic acid.

Use only if inner seal is intact.

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

Manufactured. By: Dr. Reddy’s Laboratories Tennessee LLC.Bristol, TN 37620

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PRINCIPAL DISPLAY PANEL

Principal Display Panel

NDC 43598-208-51

Amoxicillin and Clavulanate Potassium

400 mg/57 mg per 5 mL

AMOXICILLIN/CLAVULANATE POTASSIUM

FOR ORAL SUSPENSION

When reconstituted, each 5 mL contains:

AMOXICILLIN, 400 MG,

as the trihydrate

CLAVULANIC ACID, 57 MG,

as clavulanate potassium

75 mL (when reconstituted)

Rx only

Directions for mixing:

Tap bottle until all powder flows freely. Add approximately 2/3 of total water for reconstitution (total = 70 mL); shake vigorously to wet powder. Add remaining water; again 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 6 g amoxicillin and 0.855 g clavulanic acid.

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

Manufactured. By: Dr. Reddy’s Laboratories Tennessee LLC.Bristol, TN 37620

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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:43598-218 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMOXICILLIN (AMOXICILLIN ANHYDROUS) AMOXICILLIN ANHYDROUS 250 mg CLAVULANATE POTASSIUM (CLAVULANIC ACID ) CLAVULANIC ACID 125 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS SODIUM STARCH GLYCOLATE TYPE A POTATO TITANIUM DIOXIDE

Product Characteristics Color WHITE Score no score Shape OVAL Size 18mm Flavor Imprint Code AUGMENTIN;250;125; Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43598-218-78 100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE None 2 NDC:43598-218-30 30 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA050564 10/22/1990

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

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-206 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMOXICILLIN (AMOXICILLIN ANHYDROUS) AMOXICILLIN ANHYDROUS 500 mg CLAVULANATE POTASSIUM (CLAVULANIC ACID ) CLAVULANIC ACID 125 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS SODIUM STARCH GLYCOLATE TYPE A POTATO TITANIUM DIOXIDE

Product Characteristics Color WHITE Score no score Shape OVAL Size 18mm Flavor Imprint Code AUGMENTIN;500;125; Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43598-206-78 100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE None 2 NDC:43598-206-14 20 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA050564 10/22/1990

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

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-221 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 HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS SODIUM STARCH GLYCOLATE TYPE A POTATO TITANIUM DIOXIDE

Product Characteristics Color WHITE Score 2 pieces Shape CAPSULE Size 18mm Flavor Imprint Code AUGMENTIN;875 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43598-221-78 100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE None 2 NDC:43598-221-14 20 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA050720 10/02/1996

AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin and clavulanate potassium powder, for suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-213 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMOXICILLIN (AMOXICILLIN ANHYDROUS) AMOXICILLIN ANHYDROUS 200 mg in 5 mL CLAVULANATE POTASSIUM (CLAVULANIC ACID) CLAVULANIC ACID 28.5 mg in 5 mL

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE XANTHAN GUM ASPARTAME HYPROMELLOSES MANNITOL SACCHARIN SODIUM

Product Characteristics Color Score Shape Size Flavor ORANGE Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43598-213-50 50 mL in 1 BOTTLE None 2 NDC:43598-213-51 75 mL in 1 BOTTLE None 3 NDC:43598-213-52 100 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA050725 10/22/1990

AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin and clavulanate potassium powder, for suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-204 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMOXICILLIN (AMOXICILLIN ANHYDROUS) AMOXICILLIN ANHYDROUS 250 mg in 5 mL CLAVULANATE POTASSIUM (CLAVULANIC ACID) CLAVULANIC ACID 62.5 mg in 5 mL

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE XANTHAN GUM ASPARTAME HYPROMELLOSES MANNITOL SACCHARIN SODIUM

Product Characteristics Color Score Shape Size Flavor ORANGE Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43598-204-51 75 mL in 1 BOTTLE None 2 NDC:43598-204-52 100 mL in 1 BOTTLE None 3 NDC:43598-204-53 150 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA050575 10/22/1990

AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin and clavulanate potassium powder, for suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-208 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMOXICILLIN (AMOXICILLIN ANHYDROUS) AMOXICILLIN ANHYDROUS 400 mg in 5 mL CLAVULANATE POTASSIUM (CLAVULANIC ACID) CLAVULANIC ACID 57 mg in 5 mL

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE XANTHAN GUM ASPARTAME HYPROMELLOSES MANNITOL SACCHARIN SODIUM

Product Characteristics Color Score Shape Size Flavor ORANGE Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43598-208-50 50 mL in 1 BOTTLE None 2 NDC:43598-208-51 75 mL in 1 BOTTLE None 3 NDC:43598-208-52 100 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA050725 10/22/1990

Labeler — Dr. Reddy’s 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 (43598-213), manufacture (43598-204), manufacture (43598-208), manufacture (43598-218), manufacture (43598-206), manufacture (43598-221)

Establishment
Name	Address	ID/FEI	Operations
Beecham Pharmaceuticals (PTE) Limited		595132580	api manufacture (43598-218), analysis (43598-218), api manufacture (43598-221), analysis (43598-221), api manufacture (43598-213), analysis (43598-213), api manufacture (43598-204), analysis (43598-204), api manufacture (43598-208), analysis (43598-208), api manufacture (43598-206), analysis (43598-206)

Establishment
Name	Address	ID/FEI	Operations
SmithKline Beecham Limited		214482031	api manufacture (43598-218), analysis (43598-218), api manufacture (43598-206), analysis (43598-206), api manufacture (43598-221), analysis (43598-221), api manufacture (43598-213), analysis (43598-213), api manufacture (43598-204), analysis (43598-204), api manufacture (43598-208), analysis (43598-208)

Revised: 09/2016 Dr. Reddy’s Laboratories Inc