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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 CAPLET)
    2. PURPOSE
    3. USE
    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?
    16. PRINCIPAL DISPLAY PANEL

Nighttime Sleep Aid Product Label

The following document was submitted to the FDA by the labeler of this product Bi-mart. 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 Caplet)



Diphenhydramine HCl 25 mg


Purpose



Nighttime sleep-aid


Use



help reduce difficult falling asleep


Warnings




Do Not Use



  • in children under 12 years of age
  • with any other products containing diphenhydramine, even one used on skin
  • with other antihistamines

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



taking sedatives or tranquilizers.


When Using This Product



  • avoid alcoholic beverages
  • be careful when driveing a motor vehicle or operating 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 


Directions



  • adults and children 12 years of age and older: take 2 caplets at bedtime if needed or as directed by a doctor

Other Information



  • each caplet contains:calcium 30 mg

  • each caplet contains:phosphorus 15 mg

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

  • protect from moisture


Inactive Ingredients



Briliant Blue Lack, Colloidal Silicon Dioxide, Croscarmellose Sodium, Dicalcium Phosphate, Indigo Carmine Lake, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Stearic Acid, Talc, Titanium Dioxide


Questions?



Call toll-free 1-844-912-4012


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