Active Ingredient In Each Softgel
Diphenhydramine HCl 25 mg
Diphenhydramine Hcl
FDA Label NDC 48769-060
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Softech Pharma Pvt. Ltd for the product Diphenhydramine Hcl (NDC 48769-060). 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, directions, other information, inactive ingredients, principal display panel, 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 relief of occassional sleeplessness
- reduces time to fall asleep if you have difficulty falling asleep
Warnings
Do not use
- for children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
- with other drugs that causes drowsiness such as antihistamines & nighttime cold/flu products
Directions
Take only one dose per day (24 hours) - see Overdose warning
adults & children 12 yrs & over One dose = Two 25 mg Softgels (50 mg) at bedtime if needed or as directed by a doctor
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#1, FD&C red#40, gelatin, glycerin, methylparaben, polyethylene glycol, propylparaben, purified water, sorbitol, titanium dioxide
Principal Display Panel
Diphenhydramine Hydrochloride Capsules, USP 25 mg
Bag-label (Bag Label)
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