Pain relief pmextra strength tablet, coated

Ingredients and appearance - Product information

Pain relief pmextra strength tablet, coated- Acetaminophen, diphenhydramine hcl

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 36800-361
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
Starch, corn ( UNII: O8232NY3SJ)
Croscarmellose sodium ( UNII: M28OL1HH48)
D&c red no. 27 ( UNII: 2LRS185U6K)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Gelatin ( UNII: 2G86QN327L)
Glycerin ( UNII: PDC6A3C0OX)
Hypromelloses ( UNII: 3NXW29V3WO)
Maltodextrin ( UNII: 7CVR7L4A2D)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)
Povidone ( UNII: FZ989GH94E)
Water ( UNII: 059QF0KO0R)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Stearic acid ( UNII: 4ELV7Z65AP)
Titanium dioxide ( UNII: 15FIX9V2JP)
Aluminum oxide ( UNII: LMI26O6933)

Product Characteristics

Color WHITE Imprint Code BPI;50
Score 1 Shape ROUND
Size 13 mm

Marketing Information

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

Labeler - TOP CARE (Topco Associates LLC)( 006935977)