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  5. Label Information: Cvs Nighttime Sleep Aid

FDA Label for Cvs Nighttime Sleep Aid

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENTS (IN EACH 30 ML)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. OTC - DO NOT USE
    7. OTC - ASK DOCTOR
    8. OTC - ASK DOCTOR/PHARMACIST
    9. OTC - WHEN USING
    10. OTC - STOP USE
    11. OTC - PREGNANCY OR BREAST FEEDING
    12. OTC - KEEP OUT OF REACH OF CHILDREN
    13. DIRECTIONS
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS
    16. QUESTIONS OR COMMENTS?
    17. PRINCIPAL DISPLAY PANEL - 354 ML BOTTLE

Cvs Nighttime Sleep Aid Product Label

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


Active Ingredients (In Each 30 Ml)



Acetaminophen 1000 mg

Diphenhydramine HCl 50 mg


Purpose



Pain reliever

Nighttime sleep-aid


Uses



  • ▪for the temporary relief of occasional minor aches and pains with accompanying sleeplessness.

Warnings



Liver warning: This product contains acetaminophen. Severe liver damage may occur if

  • ▪adult takes more than 4 doses (30 mL each) in 24 hrs., which is the maximum daily amount for this product
  • ▪taken with other drugs containing acetaminophen
  • ▪3 or more alcoholic drinks every day while using this product

    • Allergy Alert: Acetaminophen may cause severe skin reactions.

    Symptoms may include:

    • ▪skin reddening
    • ▪blisters
    • ▪rash

      • If a skin reaction occurs, stop use and seek medical help right away


Otc - Do Not Use



Do not use

  • ▪with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • ▪for children under 12 years of age
  • ▪with any other product containing diphenhydramine, even one used on skin.

Otc - Ask Doctor



Ask a doctor before use if you have

  • •liver disease
  • •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 the blood thinning drug warfarin
  • •taking sedatives or tranquilizers

Otc - When Using



When using this product

  • •avoid alcoholic beverages
  • •drowsiness will occur
  • •do not drive a motor vehicle or operate machinery

Otc - Stop Use



Stop use and ask a doctor if

  • •pain gets worse or lasts more than 10 days
  • •fever gets worse or lasts more than 3 days
  • •new symptoms occur
  • •Sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

    • These could be signs of a serious condition.


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. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


Directions



  • ▪take only one dose (30 mL) per day (24 hours)
  • ▪Only use dose cup provided

    • adults & children 12 yrs & over

    30 mL at bedtime

    children under 12 yrs

    do not use


Other Information



  • ▪each 30 mL contains: sodium 10 mg
  • ▪store at room temperature
  • ▪very low sodium

Inactive Ingredients



citric acid, flavors, FD&C Blue No. 1, FD&C Red No. 40, glycerin, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose.


Questions Or Comments?



1-866-467-2748


Principal Display Panel - 354 Ml Bottle



Compare to the active ingredient in Vicks® ZzzQuil™ Night Pain Sleep-Aid*

NDC# 69842-448-12


Nighttime Sleep-Aid

Pain Reliever

Diphenhydramine HCl

Acetaminophen

  • •Fall Asleep Fast
  • •Max Strength Pain Reliever
  • •Non-Habit Forming

    • Berry Flavor

    Naturally and Artificially Flavored

    No Added Alcohol

    12 FL. OZ. (354 ml)

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

    Distributed by:

    CVS Nighttime Sleep Aid Berry Flavor - 975

    CVS Nighttime Sleep Aid Berry Flavor - 975


* Please review the disclaimer below.