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 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 - 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
Do not use – to make a child sleepy – with any other products 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 enlargement of the prostate gland
This unit dose package is not child resistant and is intended for institutional use only. Keep out of the reach of children.
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.
DO NOT USE IF BLISTER UNIT IS BROKEN
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 to 2 capsules |
children 6 years to under 12 years of age | 1 capsule |
children under 6 years of age | Do not use |
Inactive Ingredients
D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 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 moisture
-contains lactose
Questions or comments? (800) 616-2471
Major is a trademark owned by its respective owner
Distributed by
MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
MFGD By CPC, NY 11788
Repackaged By:
Cardinal Health
Zanesville, OH 43701
L36150280717
Principal Display Panel
Diphenhydramine HCl
Capsules 25 mg
10 Capsules
* Please review the disclaimer below.