NDC Code(s) : 0378-0833-35, 0378-0834-35
Packager : Mylan Pharmaceuticals Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-0833
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN(UNII: 804826J2HU)
(AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) 		AMOXICILLIN ANHYDROUS200 mg in 5 mL
CLAVULANATE POTASSIUM(UNII: Q42OMW3AT8)
(CLAVULANIC ACID - UNII:23521W1S24) 		CLAVULANIC ACID28.5 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ASPARTAME(UNII: Z0H242BBR1)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MANNITOL(UNII: 3OWL53L36A)
ORANGE(UNII: 5EVU04N5QU)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SUCCINIC ACID(UNII: AB6MNQ6J6L)
XANTHAN GUM(UNII: TTV12P4NEE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-0833-35100 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065066 06/10/2016
Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-0834
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN(UNII: 804826J2HU)
(AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) 		AMOXICILLIN ANHYDROUS400 mg in 5 mL
CLAVULANATE POTASSIUM(UNII: Q42OMW3AT8)
(CLAVULANIC ACID - UNII:23521W1S24) 		CLAVULANIC ACID57 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ASPARTAME(UNII: Z0H242BBR1)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MANNITOL(UNII: 3OWL53L36A)
ORANGE(UNII: 5EVU04N5QU)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SUCCINIC ACID(UNII: AB6MNQ6J6L)
XANTHAN GUM(UNII: TTV12P4NEE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-0834-35100 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065066 06/10/2016

PRINCIPAL DISPLAY PANEL

NDC 0378-0833-35

Amoxicillin and
Clavulanate
Potassium for
Oral Suspension, USP
200 mg/28.5 mg
(per 5 mL)

When reconstituted, each 5 mL
contains:

AMOXICILLIN, 200 mg,
as the trihydrate
CLAVULANIC ACID, 28.5 mg,
as clavulanate potassium

Rx only     100 mL (when reconstituted)

Use only if inner seal is intact.

Net contents: Equivalent to 4 g amoxicillin and
0.57 g clavulanic acid. Each 5 mL of reconstituted
amoxicillin and clavulanate potassium 200 mg/
28.5 mg/5 mL oral suspension contains 0.14 mEq
potassium. Store dry powder at 20°-25°C
(68°-77°F) [See USP Controlled Room Temperature].

Directions for mixing: Tap bottle until all powder
flows freely. Add approximately 2/3 of total water for
reconstitution (total = 88 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.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
Manufactured in Austria

46178949

RSDZ0833KF1

Amoxicillin and Clavulanate Potassium for Oral Suspension, USP 200 mg/28.5 mg (per 5 mL) Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 0378-0834-35

Amoxicillin and
Clavulanate
Potassium for
Oral Suspension, USP
400 mg/57 mg
(per 5 mL)

When reconstituted, each 5 mL
contains:

AMOXICILLIN, 400 mg,
as the trihydrate
CLAVULANIC ACID, 57 mg,
as clavulanate potassium

Rx only      100 mL (when reconstituted)

Use only if inner seal is intact.

Net contents: Equivalent to 8 g amoxicillin and
1.14 g clavulanic acid. Each 5 mL of reconstituted
amoxicillin and clavulanate potassium 400 mg/
57 mg/5 mL oral suspension contains 0.29 mEq
potassium. Store dry powder at 20°-25°C
(68°-77°F) [See USP Controlled Room Temperature].

Directions for mixing: Tap bottle until all powder
flows freely. Add approximately 2/3 of total water for
reconstitution (total = 84 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.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
Manufactured in Austria

46179010

RSDZ0834KF1

Amoxicillin and Clavulanate Potassium for Oral Suspension, USP 400 mg/57 mg (per 5 mL) Bottle Label