Your browser does not support JavaScript! DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]
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DIPHENHYDRAMINE HYDROCHLORIDE tablet
[Simpex Pharma Pvt. Ltd]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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

  • runny nose
  • sneezing
  • Ichy watery eyes
  • Iching of the nose or throat.

Warnings

Keep outer carton for complete warning and product information.

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin.

Consult a doctor

if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
if you are taking sedatives or tranquilizers
  • sedative, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability my occur especially in children.

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

  • marked drowsiness may occur
  • avoid alcoholic drinks

Directions

  • take every 4 to 6 hours
  • do not take more than 6 does in 24 hours
  • Adult and children 12 years of age and over - 1 to 2 tablet
  • Children 6 to 12 years of age - 1 tablet
  • Children 6 years of age - do not use this product in children under 6 years
  • Children under 4 years of age - do not use

Other Information

  • each tablet contains: Calcium 25 mg/tablet
  • store at room temperature 15 to 30 degrees Celsius (59 degrees to 86 degrees Fahrenheit)
  • protect from light and moisture
  • do not use if imprented safety seal under cap is broken or missing.

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.

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Package Label

Antihistamine 100 tablets

Diphenhydramine hydrochloride

Anti-Allergy Tablets

  • Temporarily relieves symptoms due to common cold hay fever or other allergies affecting the upper respiratory tract.
  • Runny nose
  • Sneezing
  • Ichy watery eyes
  • Iching of the nose or throat
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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:76457-002
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYSORBATE 80 
POLYVINYL ALCOHOL 
WATER 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
Colorwhite (white) Scoreno score
ShapeROUND (round) Size8mm
FlavorImprint Code ;
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76457-002-001 in 1 CARTON
1100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/15/2012
Labeler - Simpex Pharma Pvt. Ltd (916758275)
Registrant - Simpex Pharma Pvt. Ltd (916758275)
Establishment
NameAddressID/FEIBusiness Operations
Simpex Pharma Pvt. Ltd916758275manufacture(76457-002)

Revised: 11/2012
 
Simpex Pharma Pvt. Ltd

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