Headache reliefextra strength tablet, film coated

Ingredients and appearance - Product information

Headache reliefextra strength tablet, film coated- Acetaminophen, aspirin, caffeine

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 55315-159
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 250 mgin 1
Aspirin ( UNII: R16CO5Y76E)( Aspirin - UNII: R16CO5Y76E ) 250 mgin 1
Caffeine ( UNII: 3G6A5W338E)( Caffeine - UNII: 3G6A5W338E ) 65 mgin 1

Inactive Ingredients

Ingredient Name Code
Crospovidone ( UNII: 2S7830E561)
Hypromelloses ( UNII: 3NXW29V3WO)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Propylene glycol ( UNII: 6DC9Q167V3)
Sodium lauryl sulfate ( UNII: 368GB5141J)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)
Stearic acid ( UNII: 4ELV7Z65AP)
Titanium dioxide ( UNII: 15FIX9V2JP)
Starch, corn ( UNII: O8232NY3SJ)
Povidone ( UNII: FZ989GH94E)

Product Characteristics

Color WHITE Imprint Code 44;159
Score 1 Shape ROUND
Size 11 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH NOT FINAL part343 USA

Labeler - FRED'S, INC.( 005866116)

Establishment

Name ID/FEI Business Operations
FRED'S, INC. 005866116 PACK( 55315-159)