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  5. Label Information: Sleep Aid

FDA Label for Sleep Aid

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT (IN EACH TABLET)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE IF YOU ARE
    9. WHEN USING THIS PRODUCT
    10. STOP USE AND ASK A DOCTOR IF
    11. IF PREGNANT OR BREAST-FEEDING,
    12. KEEP OUT OF REACH OF CHILDREN.
    13. DIRECTIONS
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS
    16. QUESTIONS OR COMMENTS?
    17. DISTRIBUTED BY:
    18. POUCH

Sleep Aid Product Label

The following document was submitted to the FDA by the labeler of this product Spirit Pharmaceuticals 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.

Drug Facts




Active Ingredient (In Each Tablet)



Diphenhydramine HCI 50 mg


Purpose



Nighttime sleep-aid


Uses



• for relief of occasional sleeplessness


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


Ask A Doctor Or Pharmacist Before Use If You Are 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.


If Pregnant Or Breast-Feeding,



ask a health professional before use.


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) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


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 20–25°C (68–77°F)


Inactive Ingredients



FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, propylene glycol, sorbitol, titanium dioxide, water


Questions Or Comments?



1-888-333-9792


Distributed By:



Cabinet Health P.B.C.


* Please review the disclaimer below.