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

Revised: 1/2014
Document Id: 50d6dad6-66cb-40bf-9ae0-70dd6403d46d
Set id: 6175419e-9faa-4b23-bc29-24f24e958880
Version: 2
Effective Time: 20140102
 
A P J Laboratories Limited