Active Ingredient (In Each Banded Capsule)
Diphenhydramine Hydrochloride 50 mg
Diphenhydramine Hcl Capsule
FDA Label NDC 55154-0661
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 107, Llc for the product Diphenhydramine Hcl (NDC 55154-0661). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each banded capsule), purpose, keep out of reach of children, uses, warnings, directions-take every 4 to 6 hours- do not take more than 6 doses in 24 hours, inactive ingredients, package/label principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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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
Bag Label (Image 01)
* Please review the disclaimer below.
