DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride tablet 
Simpex Pharma Pvt. Ltd

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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

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:

Other Information

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:

Label2

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76457-002
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
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 CARTON02/09/2018
1100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01202/09/2018
Labeler - Simpex Pharma Pvt. Ltd (916758275)
Registrant - Simpex Pharma Pvt. Ltd (916758275)
Establishment
NameAddressID/FEIBusiness Operations
Simpex Pharma Pvt. Ltd916758275manufacture(76457-002)

Revised: 11/2023
Document Id: 0b586170-9b5f-74dc-e063-6394a90aa09b
Set id: 82771f6a-8b3d-4ffa-8b35-09c2faf3582c
Version: 5
Effective Time: 20231129
 
Simpex Pharma Pvt. Ltd