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  5. Label Information: Cvs Health Nighttime Sleep Aid

FDA Label for Cvs Health Nighttime Sleep Aid

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH 30 ML)
    3. PURPOSE
    4. USES
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. OTC - ASK DOCTOR/PHARMACIST
    8. WHEN USING THIS PRODUCT
    9. OTC - STOP USE
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PRINCIPAL DISPLAY PANEL

Cvs Health Nighttime Sleep Aid Product Label

The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy,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.

Other



Drug Facts

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.


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

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers


When Using This Product



  • •avoid alcoholic beverages

Otc - Stop Use



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.


Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Directions



  • •take only one dose per day (24 hours)
  • •Measure with dosing cup provided
    • adults & children 12 yrs & overOne Dose = 30 mL at bed time if needed or as directed by a doctorChildren under 12 yrsdo not use
     
     
     
     

Other Information



  • •each 30 mL dose contains: sodium 23 mg
  • •store at room temperature
  • •protect from light. Does not meet USP requirements for light-resistant packaging

Inactive Ingredients



anhydrous citric acid, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.


Questions Or Comments?



1-866-467-2748


Principal Display Panel



CVS Health™

Compare to the active ingredient in ZzzQuil® Nighttime Sleep-Aid

NDC 69842-753-12

Alcohol Free

Nighttime

Sleep-Aid

Diphenhydramine HCl, 50 mg

Non – habit forming

DYE FREE

BERRY FLAVOR

12 FL OZ (354 mL)

SEE NEW WARNINGS.

FAILURE TO FOLLOW THESE WARNINGS COULD RESULT IN SERIOUS CONSEQUENCES.

TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINK BAND IS MISSING OR BROKEN

*This product is not manufactured or distributed by Procter & Gamble, the distributor of ZzzQuil™ Nighttime Sleep-Aid.

DISTRIBUTED BY: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

2018 CVS/ Pharmacy

CVS .com® 1-800-SHOP CVS

CVS Quality Money Back Guarantee

CVS Health Nighttime Sleep-Aid Diphenhydramine HCl 50 mg 12 FL OZ - image 01

CVS Health Nighttime Sleep-Aid Diphenhydramine HCl 50 mg 12 FL OZ - image 01


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