NDC Code(s) : 52389-610-60
Packager : Alva-Amco Pharmacal Companies, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Tranquil Diphenhydramine Hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52389-610
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Diphenhydramine hydrochloride(UNII: TC2D6JAD40)
(Diphenhydramine - UNII:8GTS82S83M) 		Diphenhydramine hydrochloride25 mg
Inactive Ingredients
Ingredient Name Strength
Croscarmellose sodium(UNII: M28OL1HH48)
CALCIUM PHOSPHATE, MONOBASIC, ANHYDROUS(UNII: 701EKV9RMN)
Magnesium stearate(UNII: 70097M6I30)
Cellulose, microcrystalline(UNII: OP1R32D61U)
Product Characteristics
Color white Score no score
Shape ROUND Size 10 mm
Flavor Imprint Code ALVA
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52389-610-6060 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part338 08/30/2010

PRINCIPAL DISPLAY PANEL

Tranquil Nighttime PDP