DIPHENHYDRAMINE HCL- diphenhydramine hydrochloride capsule 
Cardinal Health

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.

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Diphenhydramine HCl 25 mg

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 over

take 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 age

take 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 age

ask 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 Type HUMAN OTC DRUG Item Code (Source) NDC:55154-0683(NDC:0904-5306)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
LACTOSE (UNII: J2B2A4N98G)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
Color PINK (red center band) , WHITE Score no score
Shape CAPSULE Size 6mm
Flavor Imprint Code CPC;835
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55154-0683-0 10 in 1 BAG
1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 06/03/2011
Labeler - Cardinal Health (188557102)
Establishment
Name Address ID/FEI Business Operations
Cardinal Health 188557102 REPACK(55154-0683)

Revised: 3/2015
Document Id: 5853b7fe-4a51-4d9d-9e92-2c776fe7b5f8
Set id: 30de8b4e-fe79-4de8-81b9-985c6e8be2c3
Version: 3
Effective Time: 20150331
 
Cardinal Health