NDC Code(s) : 63102-402-10
Packager : ACTIPHARMA, LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ACTIDOGESICDexbrompheniramine maleate, acetaminophen TABLET
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63102-402
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXBROMPHENIRAMINE MALEATE(UNII: BPA9UT29BS)
(DEXBROMPHENIRAMINE - UNII:75T64B71RP) 		DEXBROMPHENIRAMINE MALEATE1 mg
ACETAMINOPHEN(UNII: 362O9ITL9D)
(ACETAMINOPHEN - UNII:362O9ITL9D) 		ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40 ALUMINUM LAKE(UNII: 6T47AS764T)
FD&C YELLOW NO. 6 ALUMINUM LAKE(UNII: GYP6Z2JR6Q)
GLYCERYL MONO- AND DICAPRYLOCAPRATE(UNII: U72Q2I8C85)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
POLYVINYL ALCOHOL GRAFT POLYETHYLENE GLYCOL COPOLYMER (3:1; 45000 MW)(UNII: 23ZQ42JZZH)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A(UNII: H8AV0SQX4D)
STEARIC ACID(UNII: 4ELV7Z65AP)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color orange Score 2
Shape capsule Size 17 mm
Flavor Imprint Code A402
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63102-402-10100 in 1 BOTTLE Type 0: Not a Combination Product14/10/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M012 10/14/2016

LABELER - ACTIPHARMA, LLC(079340948)

REGISTRANT - ACTIPHARMA, LLC(079340948)

PRINCIPAL DISPLAY PANEL

ACTIDOGESIC