AMOXICILLIN AND CLAVULANATE POTASSIUM: Package Insert and Label Information (Page 4 of 4)

PRINCIPAL DISPLAY PANEL: Container Label — 200 mL

NDC 81964-203 -54
600 mg/42.9 mg per 5 mL

AMOXICILLIN AND
CLAVULANATE
POTASSIUM

for oral suspension, USP

When reconstituted, each 5 mL contains:
AMOXICILLIN, 600 mg
as the trihydrate, and
CLAVULANIC ACID, 42.9 mg
(equivalent to 51.1 mg of clavulanate potassium)

200 mL
(when reconstituted)

US

‚Äč ANTIBIOTICS Rx only

label-200mL
(click image for full-size original)
AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin and clavulanate potassium for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:81964-203
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:81964-203-51 75 mL in 1 BOTTLE None
2 NDC:81964-203-69 125 mL in 1 BOTTLE None
3 NDC:81964-203-54 200 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA050755 09/19/2022
Labeler — USAntibiotics, LLC (118085486)
Establishment
Name Address ID/FEI Operations
USAntibiotics, LLC 118085486 manufacture (81964-203), analysis (81964-203), pack (81964-203)

Revised: 09/2022 USAntibiotics, LLC

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