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Diphenhydramine Hydrochloride by Major Pharmaceuticals

Medically reviewed on September 26, 2017

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Major Pharmaceuticals
NDC Code: 0904-5306

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.

Active Ingredient (in each banded capsule)

Diphenhydramine HCl… 25 mg

Diphenhydramine HCl… 50 mg

Purpose

Antihistamine

Use

25 MG

  • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itchy throat and nose
  • Temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing

50 MG

  • 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

WARNINGS

Do not use

25 MG

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

50 MG

  • to make a child sleepy
  • with any other product containing diphenhydramine, including one applied topically

Ask a doctor before use if you have

25 MG

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

50 MG

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist

before use if you are taking sedatives or tranquilizers

When using this product
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, 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 OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions
  • Take every 4-6 hours
  • Do not take more than 6 doses in 24 hours

25 MG

adults and children 12 years of age and over1 to 2 capsules
children 6 years to under 12 years of age1 capsule
children under 6 years of agedo not use this product in children under 6 years of age

50 MG

adults and children 12 years of age and over1 capsule
children 6 years to under 12 years of ageAsk a doctor, the proper dosage strength is not available in this package**

**Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.

Other Information
  • Store at 20°C – 25°C (68°F – 77°F); excursions permitted to 15° – 30°C (59° – 86°F) [See USP Controlled Room Temperature]
  • Protect from moisture
  • Contains lactose

Inactive Ingredients

D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.

Questions?

Questions or comments? (800) 616-2471

Distributed by

MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233,
Livonia, MI 48152

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5306
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 28 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
LACTOSE 
STARCH, CORN 
Product Characteristics
ColorPINK (half pink and half clear with white powder inside, banded in red around the middle) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint Codecpc;835
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-5306-60100 CAPSULE in 1 BOTTLE
2NDC:0904-5306-801000 CAPSULE in 1 BOTTLE
3NDC:0904-5306-61100 CAPSULE in 1 BOX, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33601/02/2009
DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-2056
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 28 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
LACTOSE 
STARCH, CORN 
Product Characteristics
ColorPINK (pink, banded in red around the middle) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint Codecpc;836
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-2056-61100 CAPSULE in 1 BOX, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33601/02/2009
Labeler - Major Pharmaceuticals (191427277)
Registrant - Contract Pharmacal Corp. (968335112)
Establishment
NameAddressID/FEIOperations
Contract Pharmacal Corp.968335112MANUFACTURE(0904-5306, 0904-2056)
Establishment
NameAddressID/FEIOperations
Contract Pharmacal Corp.968334974MANUFACTURE(0904-5306, 0904-2056)

 
Major Pharmaceuticals

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Further information

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

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