Active Ingredient (In Each Banded Capsule)
Diphenhydramine HCl… 25 mg
Diphenhydramine HCl… 50 mg
Diphenhydramine Hydrochloride
FDA Label NDC 67296-1042
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Redpharm Drug, Inc. for the product Diphenhydramine Hydrochloride (NDC 67296-1042). 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, use, warnings, ask a doctor before use if you have, ask a doctor or pharmacist, when using this product, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
Use
25 MG
Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
runny nose
sneezing
itchy, watery eyes
itchy throat and nose
Temporarily relieves these symptoms due to the common cold:
runny nose
sneezing
50 MG
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
25 MG
to make a child sleepy
with any other product containing diphenhydramine, even one used on skin
50 MG
to make a child sleepy
with any other product containing diphenhydramine, including one applied topically
Ask A Doctor Before Use If You Have
25 MG
a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland
50 MG
glaucoma
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland
Ask A Doctor Or Pharmacist
before use if you are taking sedatives or tranquilizers
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
If Pregnant Or Breast-Feeding
ask a health professional before use.
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
Take every 4-6 hours
Do not take more than 6 doses in 24 hours
25 MG
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 this product in children under 6 years of age
50 MG
adults and children 12 years of age and over 1 capsule
children 6 years to 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.
Other Information
Store at 20°C – 25°C (68°F – 77°F); excursions permitted to 15° – 30°C (59° – 86°F) [See USP Controlled Room Temperature]
Protect from moisture
Contains lactose
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
17177 N Laurel Park Drive, Suite 233,
Livonia, MI 48152
Package Label.Principal Display Panel
Diph (Doc20180425143905 001)
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