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  5. Label Information: Vicks Zzzquil Night Pain Nighttime Sleep-aid Pain Reliever

FDA Label for Vicks Zzzquil Night Pain Nighttime Sleep-aid Pain Reliever

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENTS (IN EACH 30 ML)
    3. PURPOSE
    4. USE
    5. WARNINGS
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    9. WHEN USING THIS PRODUCT
    10. STOP USE AND ASK A DOCTOR IF
    11. IF PREGNANT OR BREAST-FEEDING,
    12. OTC - KEEP OUT OF REACH OF CHILDREN
    13. OVERDOSAGE
    14. DIRECTIONS
    15. OTHER INFORMATION
    16. INACTIVE INGREDIENTS
    17. QUESTIONS?
    18. PRINCIPAL DISPLAY PANEL - 354 ML BOTTLE

Vicks Zzzquil Night Pain Nighttime Sleep-aid Pain Reliever Product Label

The following document was submitted to the FDA by the labeler of this product The Procter & Gamble Manufacturing Company. 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

TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINKBAND IS BROKEN OR MISSING.

DIST. BY PROCTER & GAMBLE,

CINCINNATI, OH 45202


Active Ingredients (In Each 30 Ml)



Acetaminophen1000 mg

Diphenhydramine HCl 50 mg


Purpose



Pain reliever

Nighttime sleep-aid


Use



  • 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 you take

• more than 4 doses (30 mL each) in 24 hrs, which is the maximum daily amount for this product

• 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


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

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
  • a sodium-restricted diet

Ask A Doctor Or Pharmacist Before Use If You Are



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

When Using This Product



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

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.


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 (30 mL) per day (24 hours)
• only use the dose cup provided

adults & children 12 yrs & over30 mL at bedtime
children under 12 yrsdo not use


Other Information



  • each 30 mL dose cup contains: sodium 88 mg
  • store at no greater than 25°C and do not refrigerate

Inactive Ingredients



alcohol, citric acid, D&C Yellow No. 10, FD&C Blue No. 1, flavor, polysorbate 20, propylene glycol, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, water, xanthan gum


Questions?



1-877-881-5813


Principal Display Panel - 354 Ml Bottle



VICKS ®

ZzzQuil™
NIGHT PAIN

NIGHTTIME SLEEP-AID

PAIN RELIEVER


Diphenhydramine HCl

Acetaminophen

Fall Asleep Fast

Max Strength Pain Reliever

Non-Habit Forming

Chill Mint Flavored

Not for colds

Alcohol 10%

12 FL OZ (354 ml)

372 - 372

372 - 372


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