APHENAP- diphenhydramine hydrochloride tablet

APHENAP by

Drug Labeling and Warnings

APHENAP by is a Otc medication manufactured, distributed, or labeled by A P J Laboratories Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

active ingredient

DIPHENHYDRAMINE HYDROCHLORIDE

purpose

Antihistamine

keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away(1-800-222-1222).

uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold, sneezing, runny nose, itchy, watery eyes, itchy throat and nose

WARNINGS

Ask a doctor before use if you have glaucoma, a breathing problem such as emphysema or chronic bronchitis, trouble urinating due to an enlarged prostate gland.

directions

Adults and children 12 years and over: take 25 to 50 mg (1 to 2 tablet) every 4 to 6 hours; not more than 12 tablets in 24 hours.

Children 6 years to 12 years of age: take 25 mg (1 tablet) every 4 to 6 hours; not more than 6 tablets in 24 hours.

Children under 6 years of age: ask a doctor

inactive ingredient

CELLULOSE, MICROCRYSTALLINE

INACTIVE INGREDIENT

MAGNESIUM STEARATE

INACTIVE INGREDIENT

METHYLPARABEN

INACTIVE INGREDIENT

POVIDONE K30

INACTIVE INGREDIENT

SILICON DIOXIDE

INACTIVE INGREDIENT

SODIUM STARCH GLYCOLATE TYPE A POTATO

INACTIVE INGREDIENT

STARCH, CORN

INACTIVE INGREDIENT

TALC

INACTIVE INGREDIENT

TITANIUM DIOXIDE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

APHENAP 
diphenhydramine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46084-041
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)	30 mg
STARCH, CORN (UNII: O8232NY3SJ)	15 mg
POVIDONE K30 (UNII: U725QWY32X)	10 mg
METHYLPARABEN (UNII: A2I8C7HI9T)	1 mg
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)	1 mg
MAGNESIUM STEARATE (UNII: 70097M6I30)	10 mg
TALC (UNII: 7SEV7J4R1U)	15 mg
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)	20 mg
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)	1 mg

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	4mm
Flavor		Imprint Code	25mg
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46084-041-15	100 in 1 BLISTER PACK
2	NDC: 46084-041-14	60 in 1 BLISTER PACK
3	NDC: 46084-041-13	30 in 1 BLISTER PACK
4	NDC: 46084-041-12	12 in 1 BLISTER PACK
5	NDC: 46084-041-11	5 in 1 BLISTER PACK
6	NDC: 46084-041-23	100 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/01/2013

Labeler - A P J Laboratories Limited (677378339)

Registrant - A P J Laboratories Limited (677378339)

Establishment
Name	Address	ID/FEI	Business Operations
A P J Laboratories Limited		677378339	manufacture(46084-041)