Active Ingredient
Diphenhydramine Hydrochloride 50mg
Diphenhydramine
FDA Label NDC 52959-053
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by H.j. Harkins Company, Inc. for the product Diphenhydramine (NDC 52959-053). 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, warning, ask a doctor or pharamcist before use if you are, 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.
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
Label (Label)
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