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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. WARNINGS
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. OTC - ASK DOCTOR/PHARMACIST
    9. WHEN USING THIS PRODUCT
    10. STOP USE AND ASK A DOCTOR IF
    11. OTC - PREGNANCY OR BREAST FEEDING
    12. OTC - KEEP OUT OF REACH OF CHILDREN
    13. DIRECTIONS
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PRINCIPAL DISPLAY PANEL - 96 CT BOTTLE LABEL

Nighttime Sleep Aid Product Label

The following document was submitted to the FDA by the labeler of this product Topco Associates 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 50 mg


Purpose



Nighttime sleep-aid


Uses



  • for relief of occasional sleeplessness

Warnings



Warnings


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

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers


When Using This Product



avoid alcoholic drinks


Stop Use And Ask A Doctor If



sleeplessness persist 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



  • adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

Inactive Ingredients



FD&C Blue#1, gelatin, glycerin, polyethylene glycol-400, propylene glycol, sorbitol, titanium dioxide, water


Questions Or Comments?



1-888-333-9792


Principal Display Panel - 96 Ct Bottle Label



TOPCARE HEALTH™

Compare to  UNISOM® SLEEPGELS®active ingredient*

NIGHTTIME MAXIMUM STRENGTH

SLEEP-AID

DIPHENHYDRAMINE HCl 50 mg

NIGHTTIME SLEEP-AID

* Please review the disclaimer below.