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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 TABLET)
    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. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PRINCIPAL DISPLAY PANEL

Nighttime Sleep Aid Product Label

The following document was submitted to the FDA by the labeler of this product We Care Distributor 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 Tablet)



Diphenhydramine HCl 25 mg


Purpose



Nighttime sleep-aid


Uses



provides relief of occasional sleeplessness


Warnings




Do Not Use



  • with any other products containing diphenhydramine, even one used on skin

  • in children under 12 years of age


Ask A Doctor Before Use If You Have



  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • glaucoma

Ask A Doctor Or Pharmacist Before Use If You Are



taking sedatives or tranquilizers


When Using This Product



  • drowsiness may occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operating a machinery

Stop Use And Ask A Doctor If



sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a 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



  • do not take more than directed
  • adults and children 12 years of age and over - take 2 tablets at bedtime if needed or as directed by a doctor
  • children under 12 years of age: do not use

Other Information



  • each caplet contains; calcium 25 mg

  • store at controlled room temperature 15°-30°C (59°-86°F)

  • avoid excessive heat and humidity


Inactive Ingredients



Colloidal silicon dioxide, Croscarmellose sodium, Dicalcium phosphate, FD&C Blue #1, FD&C Blue #2, Magnesium stearate, Microcrystalline cellulose, Polyethylene glycol, Polyvinyl alcohol, Talc, Titanium dioxide


Questions Or Comments?



Call: 1-800-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com


Principal Display Panel



image 25 - 00125

image 25 - 00125


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