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  5. Label Information: Sleep Aid

FDA Label for Sleep Aid

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. IF PREGNANT OR BREAST-FEEDING,
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. PACKAGE LABEL

Sleep Aid Product Label

The following document was submitted to the FDA by the labeler of this product Kareway Product, 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 25mg


Purpose



Nighttime sleep-aid


Use



helps reduce difficulty falling asleep


Warnings



Do not use

  • in 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



  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • 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


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 accidental overdose get medical help or contact a Poison Control Center right away.


Directions



  • adults and children 12 years and older

    • take 2 tablets at bedtime if needed or as directed by your doctor.


Other Information



  • each tablet contains:calcium 0.2mg
  • store at room temperature
  • avoid excessive heat (greater than 100°F) or humidity

Inactive Ingredients



FDC blue #1, microcrystalline cellulose, lactose anhydrous, sodium starch glycolate, corn starch, dicalcium phosphate, stearic acid, silcon dioxide, magnesium stearate, hypromellose, polyethyleneglycol, titanium dioxide, ethanol


Package Label



Enter section text here

image of Sleep-aid carton - sleepaid.carton

image of Sleep-aid carton - sleepaid.carton


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