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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. OTC - ASK DOCTOR
    7. OTC - ASK DOCTOR/PHARMACIST
    8. OTC - WHEN USING
    9. OTC - STOP USE
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. OVERDOSAGE
    13. DIRECTIONS
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS
    16. QUESTIONS?
    17. 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 seal around the neck is broken or missing.

DIST. BY PROCTER & GAMBLE,

CINCINNATI, OH 45202


Active Ingredients (In Each 30 Ml)



Acetaminophen 1000 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


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
  • a sodium-restricted diet

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.


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 contains: sodium 151 mg
  • store at no greater than 25°C and do not refrigerate

Inactive Ingredients



alcohol, citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavors, 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

Midnight Berry

Not for colds

Alcohol 10%

12 FL OZ (354 ml)

598 - 598

598 - 598


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