Active Ingredient (In Each Softgel)
Diphenhydramine HCl 50 mg
Sleepaid Softgels Capsule, Liquid Filled
FDA Label NDC 72090-023
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pioneer Life Sciences, Llc for the product Sleepaid Softgels (NDC 72090-023). 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, do not use:, ask a doctor before use if you have, directions:, other information:, inactive ingredients:, 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 occasional sleeplessness
Do Not Use:
- for children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin.
Ask A Doctor Before Use If You Have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland.
Directions:
Adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor.
Other Information:
store between 15-30°C (59-86°F). Avoid high humidity. Protect from light.
Inactive Ingredients:
Polyethylene Glycol, Gelatin, Sorbitol, Sorbitan Anhydrous, Glycerin, Brilliant Blue FCF.
Questions Or Comments?
Call toll-free 1 (732) 689-5070 Monday through Friday 9 am to 5 pm EST.
* Please review the disclaimer below.
