Active Ingredient
Diphenhydramine Hydrochloride 25 mg
Diphenhydramine Hydrochloride
FDA Label NDC 63187-771
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Proficient Rx Lp for the product Diphenhydramine Hydrochloride (NDC 63187-771). 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, purpose, use, warnings: do not use, ask a doctor before use if you have, when using this product, pregnancy/breast-feeding warning, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
Use
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.
Warnings: Do Not Use
• to make a child sleepy
• with any other product containing diphenhydramine, even one used on skin
Ask A Doctor Before Use If You Have
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• trouble urinating due to an enlarged prostate gland
When Using This Product
• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children
Pregnancy/Breast-Feeding Warning
If pregnant or breast-feeding, ask a health professional before use.
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.
Directions
Adults and children 12 years and over: take 25 to 50 mg (1 to 2 capsule) every 4 to 6 hours, not more than 12 capsules in 24 hours.
Children 6 years to 12 years of age: take 12.5 mg** (1 capsule) every 4 to 6 hours, not more than 6 capsules in 24 hours.
Children under 6 years of age: do not use
**12.5mg dosage strength is not available in this package. Do not attempt to break capsule
Other Information
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. Protect from excessive moisture.
Inactive Ingredients
D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.
Questions?
Questions or comments? (800) 616-2471
Distributed by
MAJOR® PHARMACEUTICALS
31778 Enterprise Drive
Livonia, MI 48150 USA
Repackaged by:
Proficient Rx LP
Thousand Oaks, CA 91320
Re-Order No. 301574
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