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Diphenhydramine HCl by Cardinal Health

Medically reviewed on January 19, 2018

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Cardinal Health
NDC Code: 55154-0683

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 HCl Capsules 25 mg

Active ingredient (in each banded capsule)

Diphenhydramine Hydrochloride 25 mg

Purpose

Antihistamine

Keep Out of Reach of Children

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

Uses-

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.

When using this product:

Marked drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
use caution when driving a motor vehicle or operating machinery
excitability may occur, especially in children

Warnings

Do not use – to make a child sleepy – with any other products containing diphenhydramine, including one applied topically

Ask a doctor before use if you have –glaucoma -a breathing problem such as emphysema or chronic bronchitis –difficulty in urination due to enlargement of the prostate gland

This unit dose package is not child resistant and is intended for institutional use only. Keep out of the reach of children.

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

If pregnant or breast-feeding, ask a health professional before use. In case of overdose, get medical help or contact a Poison Control Center right away.

DO NOT USE IF BLISTER UNIT IS BROKEN

Directions
-Take every 4 to 6 hours – do not take more than 6 doses in 24 hours

adults and children 12 years of age and over

1 to 2 capsules

children 6 years to under 12 years of age

1 capsule

children under 6 years of age

Do not use

Inactive ingredients

D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, Gelatin, Lactose and Starch

Storage

Store at 20-25 C (68-77 F); excursions permitted to 15-30 C (59-86 F). [See USP Controlled Room Temperature].

-protect from moisture

-contains lactose

Questions or comments? (800) 616-2471

Major is a trademark owned by its respective owner

Distributed by

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

MFGD By CPC, NY 11788

Repackaged By:

Cardinal Health

Zanesville, OH 43701

L36150280717

Principal Display Panel

Diphenhydramine HCl

Capsules 25 mg

10 Capsules

DIPHENHYDRAMINE HCL 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-0683(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, UNSPECIFIED 
LACTOSE, UNSPECIFIED FORM 
STARCH, CORN 
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize14mm
FlavorImprint Codecpc;835
Contains    
Packaging
#Item CodePackage Description
1NDC:55154-0683-010 BLISTER PACK in 1 BAG
11 CAPSULE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33606/03/2011
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIOperations
Cardinal Health188557102REPACK(55154-0683)

 
Cardinal Health

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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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