FDA Label for Diphenhydramine Hcl
View Indications, Usage & Precautions
Diphenhydramine Hcl Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health 107, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
Repackaged By:
Cardinal Health
Zanesville, OH 43701
L32991871115
Package/Label Principal Display Panel
Diphenhydramine HCl
Capsules 50 mg.
10 Capsules
* Please review the disclaimer below.