Active Ingredient (In Each Softgel)
Diphenhydramine HCl 25 mg
Diphenhydramine Hydrochloride
FDA Label NDC 82501-1578
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gobrands, Inc for the product Diphenhydramine Hydrochloride (NDC 82501-1578). 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 (in each softgel), purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Nighttime sleep-aid
Uses
● for the relief of occasional sleeplessness ● reduces time to fall asleep if you have difficulty falling asleep
Warnings
Otc - Do Not Use
Do not use ● for children under 12 years of age ● with any other product containing diphenhydramine, even one used on skin
Otc - Ask Doctor
Ask a doctor before use if you have ● a breathing problem such as asthma, emphysema, or chronic bronchitis ● glaucoma ● difficulty in urination due to enlargement of the prostate gland
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use ifyou are taking sedatives, tranquilizers or any other sleep aid
Otc - Stop Use
Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - 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. (1-800-222-1222)
Directions
take only one dose per day (24 hours)
| adults & children 12 years & over | One dose = TWO 25 mg softgels (50 mg) at
bed time if needed or as directed by a doctor |
| children under 12 years | do not use |
Other Information
● store at 20-25° C (68-77° F) ● avoid excessive heat above 40° C (104° F) and high humidity
● Protect from light
Inactive Ingredients
FD&C Blue No. 1, FD&C Red No. 40, gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide.
Questions Or Comments?
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