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 H.j. Harkins Company, Inc.. 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 Hydrochloride 50mg
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.
Warning
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.
Ask A Doctor Or Pharamcist Before Use If You Are
taking tranquilizers or sedatives.
When Using This Product
you may get drowsy; 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. Do not use any other products containing diphenhydramine.
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 25 mg (1 capsule) every 4 to 6 hours; not more than 6 capsules in 24 hours.
Children under 6 years of age: ask a doctor.
Other Information
Store at controlled room temperature 59-86 degrees F.
Inactive Ingredients
Lactose, starch, gelatin with bisulfites and artificial colors.
Questions?
Adverse drug event call: (800) 616-2471
Repacked by:
H.J. Harkins Company, Inc.
Grover Beach, CA 93433
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Label
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