Acetaminophen and Codeine Phosphate (Page 7 of 7)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL – 300 mg/30 mg (30 Tablet Blisterpack)

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ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67046-929(NDC:13107-059)
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 300 mg
CODEINE PHOSPHATE (CODEINE ANHYDROUS) CODEINE PHOSPHATE 30 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CROSPOVIDONE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
STARCH, CORN
SODIUM LAURYL SULFATE
STEARIC ACID
Product Characteristics
Color white (White to Off White) Score no score
Shape ROUND (Flat-faced, Beveled Edge) Size 11mm
Flavor Imprint Code U36
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67046-929-30 30 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202800 01/05/2017
Labeler — Contract Pharmacy Services-PA (945429777)
Establishment
Name Address ID/FEI Operations
Coupler Enterprises 945429777 repack (67046-929)

Revised: 12/2018 Contract Pharmacy Services-PA

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