DIPHENHYDRAMINE HCL- diphenhydramine hcl capsule 
Cardinal Health 107, LLC

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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Drug Facts

Active ingredient (in each banded capsule)

Diphenhydramine Hydrochloride 50 mg

Purpose

Antihistamine

Keep Out of Reach of Children

Keep out of reach of children.

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

Ask a doctor before use if you have glaucoma, a breathing problem such as emphysema or chronic bronchitis, trouble urinating due to an enlarged prostate gland.

This package is intended for institutional use only. 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.

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 capsule

children under 12 years of age

ask 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.

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

Protect from moisture

- contains lactose

DO NOT USE IF BLISTER UNIT IS BROKEN

Warnings

Do not use - to make a child sleepy - with any other product 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 an enlargement of the prostate gland

Inactive ingredients

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

Questions or comments? (800) 616-2471

Distributed by

MAJOR® PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI 48150 USA

MFGD By CPC, NY 11788

Re-Order No. 301575

Distributed By:

Cardinal Health

Dublin, OH 43017

L32991870218

Package/Label Principal Display Panel

Diphenhydramine HCl

Capsules 50 mg.

10 Capsules

bag label
DIPHENHYDRAMINE HCL 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-0661(NDC:0904-2056)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 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)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorPINK (red center band) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint Code CPC;836
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-0661-010 in 1 BAG01/02/2009
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/02/2009
Labeler - Cardinal Health 107, LLC (118546603)

Revised: 11/2022
Document Id: c7d0aacc-bf97-41cf-bec5-a8f0975e4890
Set id: abc0e348-8532-4658-bd8c-d7dbe5a28c7d
Version: 11
Effective Time: 20221118
 
Cardinal Health 107, LLC