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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 30 ML)
    2. PURPOSE
    3. USES
    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. PACKAGE/LABEL 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 30 Ml)



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

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 enlargement of the 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 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)
  • •only use the dose cup provided

    • adults & children 12 yrs & over

    30 mL at bed time if needed or as directed by a doctor

    children under 12 yrs

    do not use


Other Information



  • •each 30 mL contains: sodium 20 mg
  • •store at 20-25°C (68-77°F)

Inactive Ingredients



alcohol, anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, poloxamer 407, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate


Questions Or Comments?



1-800-934-1204


Package/Label Principal Display Panel



Compare to Vicks® ZzzQuil® active ingredient

#1 DOCTOR RECOMMENDED sleep-aid active ingredient

SLEEP-AID

DIPHENHYDRAMINE HCl 50 mg PER 30 mL

NIGHTTIME SLEEP-AID

NON-HABIT FORMING

NOT FOR TREATING COLD OR FLU

10% ALCOHOL

100% MONEY-BACK GUARANTEE

THREE 12 FL OZ (355 mL) BOTTLES

BERRY FLAVOR

GLUTEN FREE

TOTAL 36 FL OZ (2.25 pt) 1.06L

sleep aid image - image 01

sleep aid image - image 01


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