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  5. Label Information: Berkley And Jensen Sleep Aid

FDA Label for Berkley And Jensen Sleep Aid

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    2. PURPOSE
    3. USE
    4. DO NOT USE
    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. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL

Berkley And Jensen Sleep Aid Product Label

The following document was submitted to the FDA by the labeler of this product Bjwc. 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)



Doxylamine succinate 25 mg


Purpose



Nighttime sleep-aid


Use



  • •helps to reduce difficulty in falling asleep

Do Not Use



in children under 12 years of age


Ask A Doctor Before Use If You Have



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

Ask A Doctor Or Pharmacist Before Use If You Are



taking any other drugs


When Using This Product



  • •avoid alcoholic beverages
  • •take only at bedtime

Stop Use And Ask A Doctor If



  • •sleeplessness persists continuously for more than two 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



  • •adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor
  • •children under 12 years of age: do not use

Other Information



  • •store at 68°-77°F (20°-25°C)
  • •retain in carton until time of use
  • •see carton end panel for lot number and expiration date

Inactive Ingredients



anhydrous dibasic calcium phosphate, dibasic calcium phosphate dihydrate, FD&C blue no. 1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate


Questions Or Comments?



1-800-934-1204


Principal Display Panel



Compare to the active ingredient in Unisom® SleepTabs®

SLEEP AID

DOXYLAMINE SUCCINATE TABLETS, 25mg

NIGHTTIME SLEEP-AID

100% MONEY-BACK GUARANTEE

ACTUAL SIZE

GLUTEN FREE

192 TABLETS

ONE TABLET PER DOSE

2-96 COUNT BOTTLES


* Please review the disclaimer below.