FDA Label for Diphenhydramine
View Indications, Usage & Precautions
Diphenhydramine Product Label
The following document was submitted to the FDA by the labeler of this product Rebel Distributors Corp. 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
Diphenhydramine HCl 25mg
Diphenhydramine HCl 50mg
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
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