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  5. Label Information: Zzzquil Nightime Sleep-aid

FDA Label for Zzzquil Nightime Sleep-aid

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH LIQUICAP)
    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?
    15. PACKAGE LABELING:

Zzzquil Nightime Sleep-aid Product Label

The following document was submitted to the FDA by the labeler of this product Navajo Manufacturing Company 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 Liquicap)



Diphenhydramine hydrochloride 25 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.


Directions



take only one dose per day (24 hours)

 adults & children 12 yrs & over 2 LiquiCaps at bedtime if needed or as directed by a doctor
 children under 12 yrs do not use


Other Information



• store at 20-25°C (68-77°F)
• avoid excessive heat above 40°C (104°F)
• protect from light


Inactive Ingredients



FD&C Blue No. 1, FD&C Red No. 40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide


Questions?



1-877-881-5813


Package Labeling:



ZzzQuil - ZzzQuil

ZzzQuil - ZzzQuil


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