APHENAP - diphenhydramine hydrochloride tablet 
A P J Laboratories Limited

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

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

MAGNESIUM STEARATE


METHYLPARABEN

POVIDONE K30

SILICON DIOXIDE

SODIUM STARCH GLYCOLATE TYPE A POTATO

STARCH, CORN

TALC

TITANIUM DIOXIDE

product
APHENAP 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:46084-041
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE30 mg
STARCH, CORN15 mg
POVIDONE K3010 mg
METHYLPARABEN1 mg
TITANIUM DIOXIDE1 mg
MAGNESIUM STEARATE10 mg
TALC15 mg
SODIUM STARCH GLYCOLATE TYPE A POTATO20 mg
SILICON DIOXIDE1 mg
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize4mm
FlavorImprint Code 25mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46084-041-15100 in 1 BLISTER PACK
2NDC:46084-041-1460 in 1 BLISTER PACK
3NDC:46084-041-1330 in 1 BLISTER PACK
4NDC:46084-041-1212 in 1 BLISTER PACK
5NDC:46084-041-115 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/01/2013
Labeler - A P J Laboratories Limited (677378339)
Registrant - A P J Laboratories Limited (677378339)
Establishment
NameAddressID/FEIBusiness Operations
A P J Laboratories Limited677378339manufacture(46084-041)

Revised: 2/2013
Document Id: 552c493c-598b-466e-9c1a-b6dc7dbb7048
Set id: 6175419e-9faa-4b23-bc29-24f24e958880
Version: 1
Effective Time: 20130228
 
A P J Laboratories Limited