Pain reliever pm tablet, film coated

Ingredients and appearance - Product information

Pain reliever pm tablet, film coated- Acetaminophen and diphenhydramine hcl

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 15127-325
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 ) 25 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Croscarmellose sodium ( UNII: M28OL1HH48)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)
Povidone ( UNII: FZ989GH94E)
Stearic acid ( UNII: 4ELV7Z65AP)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)
Starch, corn ( UNII: O8232NY3SJ)

Product Characteristics

Color BLUE Imprint Code 44;235
Score 1 Shape OVAL
Size 17 mm

Marketing Information

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

Labeler - L&R Distributors, Inc.( 012578514)

Establishment

Name ID/FEI Business Operations
L&R Distributors, Inc. 012578514 PACK( 15127-325)