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  5. Label Information: Nighttime Sleep-aid

FDA Label for Nighttime Sleep-aid

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH SOFTGEL)
    3. PURPOSE
    4. USES
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS
    10. QUESTIONS OR COMMENTS?
    11. PRINCIPAL DISPLAY PANEL

Nighttime Sleep-aid Product Label

The following document was submitted to the FDA by the labeler of this product Puracap Pharmaceutical 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.

Other



Drug Facts


Active Ingredient (In Each Softgel)



Diphenhydramine HCl 25 mg


Purpose



Nighttime sleep-aid


Uses



  • for the relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep

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 cause drowsiness such as antihistamines and nighttime cold/flu products

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
  • heart disease

Directions



  • take only one dose per day (24 hours) - see Overdose warning
    •  adults and children 12 years and over ONE dose = TWO 25 mg softgels (50 mg) at bed time if needed or as directed by a doctor                                                              


Other Information



  • store at 15-30° C (59-86° 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, polyethylene glycol, purified water, sorbitol special, and white edible ink


Questions Or Comments?



Call toll free 1-855-215-8180


Principal Display Panel



Nighttime Sleep-Aid
Diphenhydramine HCl, 25 mg

Compare to Vicks® ZzzQuil® LiquiCaps® Active Ingredient*

12 Softgels

NDC 51013-104-02

Distributed by: Greenbrier International, Inc.

500 Volvo Parkway, Chesapeake, VA 23320

*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® ZzzQuil® LiquiCaps®.


* Please review the disclaimer below.