DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride tablet 
Simpex Pharma Pvt. Ltd

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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Diphenhydramine hydrochloride

Active ingredient (in each tablet)

Diphenhydramine hydrochloride 25 mg

Purpose

Antihistamine

Uses

Temporarily relieves symptoms due to common cold, hay fever or other allergies affecting the upper respiratory tract

Warnings

Keep outer carton for complete warning and product information.

Do not use


Consult a doctor

if you have

if you are taking sedatives or tranquilizers

Pregnancy or breast feeding

If Pregnant or breast-feeding, ask a health professional before use.

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.

When using this product

Directions

Other Information

Inactive ingredient

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, lecithin*, magnesium stearate, microcrystalline cellulose, opadry AMB white*, polyethylene glycol (PEG) 400, polysorbate 80, polyvinyl alcohol*, purified water*, talc*, and titanium dioxide. *contains one or more of these ingredients.

Questions or comments?

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Package Label

Antihistamine 100 tablets

Diphenhydramine hydrochloride

Anti-Allergy Tablets

SIMPEX

Manufactured by:
SIMPEX PHARMA PVT. LTD.
C-7 to C-13 and C-59 to C-64, Siggadi Growth Center
(SIDCUL), Siggadi, Kotdwar-246149,
District Pauri Garhwal, Uttrakhand, India
Distributed by:
Lot. No. :
Mfg.Date:
Exp.Date:

carton

bottle

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76457-002
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
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
WATER (UNII: 059QF0KO0R)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color white (white) Score no score
Shape ROUND (round) Size 8mm
Flavor Imprint Code ;
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:76457-002-00 1 in 1 CARTON
1 100 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 11/15/2012
Labeler - Simpex Pharma Pvt. Ltd (916758275)
Registrant - Simpex Pharma Pvt. Ltd (916758275)
Establishment
Name Address ID/FEI Business Operations
Simpex Pharma Pvt. Ltd 916758275 manufacture(76457-002)

Revised: 11/2012
Document Id: 02ac9591-9bec-49ef-8751-feb461860024
Set id: 82771f6a-8b3d-4ffa-8b35-09c2faf3582c
Version: 1
Effective Time: 20121115
 
Simpex Pharma Pvt. Ltd