DIPHENHYDRAMINE HCL- diphenhydramine hydrochloride capsule 
Cardinal Health

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Active ingredient

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 and itchy throat and nose.

When using this product:

  • you may get drowsy
  • 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
  • do not use any other products containing diphenhydramine

Warnings

Ask a doctor before use if you have glaucoma, a breathing problem such as emphysema or chronic bronchitis or trouble urinating due to an enlarged prostate gland. This package is intended for institutional use only. Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedative. If pregnant or breast-feeding, ask a health professional before use.

Directions

adults and children 12 years and overtake 25 to 50 mg (1 to 2 capsule) every 4 to 6 hours; not more than 12 capsules in 24 hours.
children 6 years to under 12 years of agetake 12.5 mg** to 25 mg (1 capsule) every 4 to 6 hours; not more than 6 capsules in 24 hours.
children under 6 years of ageask a doctor
**12.5 mg dosage strength is not available in this package. Do not attempt to break capsule.

Inactive ingredients

D&C Red #28, FD&C Blue #1, FD&C Red #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 excessive moisture.

Distributed by

Major Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150 USA

Questions? Adverse Drug

Event Call: (800) 616-2471

MFGD By Contract Pharm., NY 11788

Principal Display Panel

Diphenhydramine HCl

Capsules 25 mg

10 Capsules

bag label
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 
LACTOSE 
STARCH, CORN 
Product Characteristics
ColorPINK (red center band) , WHITEScoreno score
ShapeCAPSULESize6mm
FlavorImprint Code CPC;835
Contains    
Packaging
#Item CodePackage Description
1NDC:55154-0683-010 in 1 BAG
11 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/03/2011
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIBusiness Operations
Cardinal Health188557102REPACK

Revised: 07/2011
Document Id: 30de8b4e-fe79-4de8-81b9-985c6e8be2c3
Set id: 30de8b4e-fe79-4de8-81b9-985c6e8be2c3
Version: 1
Effective Time: 20110725
 
Cardinal Health