Active Ingredient
Diphenhydramine HCl 25mg
Diphenhydramine HCl 50mg
Diphenhydramine
FDA Label NDC 21695-500
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Diphenhydramine (NDC 21695-500). 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, uses, warnings, directions, other information, 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
Uses
Temporarily relieves: ° hay fever or other upper respiratory allergies like: ° runny nose
° sneezing ° watery eyes ° itchy nose or throat
Warnings
Do not use with any other product containing Diphenhydramine HCl, including one applied topically.
Ask a doctor or pharmacist before use if you have ° trouble urinating due to enlarged prostate gland ° a breathing problem such as emphysema or chronic bronchitis ° glaucoma ° if you are taking sedatives or tranquilizers
When using this product ° avoid alcoholic drinks ° marked drowsiness may occur ° excitability may occur, especially in children ° alcohol, sedatives & tranquilizers may increase drowsiness ° be careful when driving a motor vehicle or operating machinery.
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 4-6 hours
° do not take more than 6 doses in 24 hours.
Adults & children 12 years & over: 1-2 capsules
Children 6 to under 12 years: 1 capsule
Children under 6: ask a doctor
Other Information
Store at room temperature 15°-30°C (59°-86°F)
Protect from excessive moisture
Inactive Ingredients
Lactose Monohydrate, Silicon Dioxide, Magnesium Steareate, Black Iron Oxide, Gelatin, Sodium Lauyl Sulfate, D&C Red No. 28, FD&C Red No. 40, FD&C Blue No. 1.
Distributed by:
SDA Laboratories, Inc.
Greenwich, CT 06830
Repackaged by:
Rebel Distributors Corp
Thousand Oaks, CA 91320
Package/Label Principal Display Panel
Diphenhydramine HCl 25mg (C46e1443 Dffe 47a9 Bc9a Acbe3a8b0b41 01)
Diphenhydramine HCl 50mg (C46e1443 Dffe 47a9 Bc9a Acbe3a8b0b41 02)
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