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diphenhydramine hydrochloride by Simpex Pharma Pvt. Ltd

Dosage form: tablet
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Simpex Pharma Pvt. Ltd
NDC Code: 76457-002

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.

Diphenhydramine hydrochloride

Drug Facts

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
  • Itchy watery eyes
  • Itching of the nose or throat.

Warnings

Do not use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin.

Consult your doctor if you have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland.

Consult your doctor if you are taking sedatives or tranquilizers
  • sedative, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur especially in children.

If Pregnant or breast-feeding,

ask a health professional before use.

Keep out or reach of children.

In case of overdose, get medical help or contact a poison control center right away.

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

Other Information
  • each tablet contains: Calcium 25 mg/tablet
  • store at room temperature 15°-30° (59°-86° F)
  • protect from light and moisture

Inactive ingredient

carnauba wax, colloidal anhydrous silica, croscarmellose sodium, dibasic calcium phosphate, hydroxy propyl methyl cellulose phthalate HP-55, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, polyvinyl alcohol, talc, titanium dioxide, xanthan gum,

Package Labeling:

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem 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 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOL 400 
POLYSORBATE 80 
POLYVINYL ALCOHOL, UNSPECIFIED 
TALC 
TITANIUM DIOXIDE 
XANTHAN GUM 
Product Characteristics
Colorwhite (white) Scoreno score
ShapeROUND (round) Size8mm
FlavorImprint Code;
Contains    
Packaging
#Item CodePackage Description
1NDC:76457-002-001 BOTTLE in 1 CARTON
1100 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/09/2018
Labeler - Simpex Pharma Pvt. Ltd (916758275)
Registrant - Simpex Pharma Pvt. Ltd (916758275)
Establishment
NameAddressID/FEIOperations
Simpex Pharma Pvt. Ltd916758275manufacture(76457-002)

 
Simpex Pharma Pvt. Ltd

← See all diphenhydramine hydrochloride brands

Medically reviewed on Feb 14, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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