Purpose
Antihistamine
Antihistamine
Diphenhydramine Hydrochloride
FDA Label NDC 67296-0876
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 67296-0876). 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 purpose, uses, warnings, keep out of the reach of children., directions, storage and handling, inactive ingredients, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies
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runny nose and sneezing
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itching of the nose or throat
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itchy, watery eyes.
Warnings
Ask a doctor before use if you have
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a breathing problem such as emphysema or chronic bronchitis
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glaucoma
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difficulty in urination due to enlargement of the prostate gland
Do not use with any other product containing diphenhydramine, including products used topically.
Ask a doctor or pharmacist before use if you are
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taking tranquilizers or sedatives
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taking other products containing diphenhydramine
When using this product
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Do not exceed recommended dosage
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excitability may occur, especially in children
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marked drowsiness may occur
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alcohol, sedatives, and tranquilizers may increase drowsiness
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avoid alcoholic drinks
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use caution when driving a motor vehicle or operating machinery
If pregnant or breastfeeding ask a health professional before use.
Keep Out Of The Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
DIRECTIONS
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Adults and Children 12 years and over: 25 to 50 mg (1 to 2 capsules) every 4 to 6 hours, not to exceed 12 capsules in 24 hours.
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Children 12 years and under: Consult a Doctor
Storage And Handling
Keep tightly closed. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Manufactured for Sandoz Inc.
Princeton, NJ 08540
Manufactured by Epic Pharma, LLC
Laurelton, NY 11413
L1812
Rev. 11/08
Inactive Ingredients
Colloidal Silicon Dioxide, Corn Starch, D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Anhydrous Lactose, Magnesium Stearate, Silicon Dioxide and Sodium Lauryl Sulfate.
Dosage & Administration
Adults and Children 12 years and over: 25 to 50 mg (1 to 2 capsules) every 4 to 6 hours, not to exceed 12 capsules in 24 hours.
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Children 12 years and under: Consult a Doctor
Active Ingredient Section
Diphenhydramine Hydrochloride 25 mg
Diphenhydramine Hydrochloride 50 mg
Package Label - Principal Display Panel
67296-0876 (Doc20161201150824 001)
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