DIPHENHYDRAMINE HCL- diphenhydramine hcl 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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Diphenhydramine HCl 25 mg

Active ingredient

Drug Facts

In each capsule: Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Keep Out of Reach of Children

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

Uses

Temporarily relieves runny nose and decreases sneezing, itching of the nose and throat, itchy-watery eyes due to hay fever or other respiratory allergies.

Warnings

This package is intended for institutional use only. If pregnant or breast-feeding, ask a health professional before use.

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

Ask a doctor before use if you are: taking any drugs for asthma or are taking sedatives or tranquilizers.

When using this product: drowsiness may occur, avoid alcoholic beverages, alcohol, sedatives and tranquilizers may increase the drowsiness effect, use caution when driving a motor vehicle or operating machinery, excitability may occur, especially in children.

Directions

Do not use more than directed. Adults and children: (12 years of age and over) Take 1 capsule every 4 to 6 hours as needed. Do not take more than 12 capsules in 24 hours. Children under 12 years: ask a doctor.

Inactive ingredients

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

Other

MEDI-FIRST®

Mfg. for Medique Products

Wood Dale, IL 60191 USA

Repackaged by Cardinal Health

Zanesville, OH 43701

Principal Display Panel

Diphenhydramine HCl

25 mg

10 Capsules

bag label
DIPHENHYDRAMINE HCL 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-2750(NDC:47682-858)
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
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorPINK, WHITEScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code CPC;835
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-2750-010 in 1 BAG06/03/201105/31/2015
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/03/201105/31/2015
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIBusiness Operations
Cardinal Health188557102REPACK(55154-2750)

Revised: 6/2017
 
Cardinal Health