FDA Label for Sleepaid Softgels

View Indications, Usage & Precautions

Sleepaid Softgels Product Label

The following document was submitted to the FDA by the labeler of this product Pioneer Life Sciences, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Softgel)



Diphenhydramine HCl 50 mg


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.