Allergy tablet

Ingredients and appearance - Product information

Allergy tablet- Acetaminophen and diphenhydramine hcl

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 55315-518
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 500 mgin 1
Diphenhydramine hydrochloride ( UNII: TC2D6JAD40)( Diphenhydramine - UNII: 8GTS82S83M ) 12.5 mgin 1

Inactive Ingredients

Ingredient Name Code
Carnauba wax ( UNII: R12CBM0EIZ)
Starch, corn ( UNII: O8232NY3SJ)
Croscarmellose sodium ( UNII: M28OL1HH48)
Crospovidone ( UNII: 68401960MK)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
D&c yellow no. 10 ( UNII: 35SW5USQ3G)
Hypromelloses ( UNII: 3NXW29V3WO)
Magnesium stearate ( UNII: 70097M6I30)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Polydextrose ( UNII: VH2XOU12IE)
Polyethylene glycols ( UNII: 3WJQ0SDW1A)
Povidones ( UNII: FZ989GH94E)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Stearic acid ( UNII: 4ELV7Z65AP)
Titanium dioxide ( UNII: 15FIX9V2JP)
Triacetin ( UNII: XHX3C3X673)

Product Characteristics

Color YELLOW Imprint Code 44;518
Score 1 Shape CAPSULE
Size 19 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( 55315-518)