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  5. Label Information: Nighttime Sleep Aid

FDA Label for Nighttime Sleep Aid

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH SOFTGEL)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING,
    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. QUESTIONS ?
    18. OTHER INFORMATION- STORAGE
    19. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Nighttime Sleep Aid Product Label

The following document was submitted to the FDA by the labeler of this product Ascent Consumer Products, Inc. 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 the relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep

Warnings



Do not use

for children under 12 years if 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

difficulty in urniation due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedative or tranquilizers

When usiing this product avoid alcoholic beverages

Keep out of reach of children


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
  • difficulty in urination due to an enlargement of the prostate gland

    • a breathing problem such as emphysema or chronic bronchitis

    glaucoma

    difficulty in urination due to enlargement of the prostate gland


Ask A Doctor Or Pharmacist Before Use If You Are



taking sedatives or tranquilizers

taking sedative or tranquilizers


When Using This Product



  • avoid alcoholic beverages

Stop Use And Ask A Doctor If



sleeplessness persists 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).


Directions



  • take only one dose per day (24 hours)- see overdose warning
    • adults & children 12 yrs & over

    1 softgel(50mg) at bedtime if needed or as directed by a doctor


Other Information



  • store at 20-25 °C (68-77 °F)
  • avoid excessive heat above 40 oC (104 oF)
  • protect from light

Inactive Ingredients



edible dye free ink, gelatin, glycerin, polyethylene glycol, purified water, sorbitol


Questions Or Comments?



1-800-719-9260


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