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  5. Label Information: Vicks Painquil Pm Pain Reliever Plus Nighttime Sleep-aid

FDA Label for Vicks Painquil Pm Pain Reliever Plus Nighttime Sleep-aid

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. OTC - ASK DOCTOR
    8. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    9. STOP USE AND ASK A DOCTOR IF
    10. WHEN USING THIS PRODUCT
    11. IF PREGNANT OR BREAST-FEEDING,
    12. 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 Painquil Pm Pain Reliever Plus Nighttime Sleep-aid 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)



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 3 doses (30 mL each) in 24 hours, 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

    Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.


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

Ask A Doctor Or Pharmacist Before Use If You Are



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

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
  • redness or swelling is present
  • 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.


When Using This Product



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

If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.




Overdosage



In case of overdose, get medical help or contact a Poison Control Center right away. 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 the dose cup provided
  • only use as directed
    • adults & children 12 yrs & over30 mL at bedtime
    children under 12 yrsdo not use


Other Information



  • each 30 mL dose contains: sodium 21 mg
  • store at no greater than 25°C (77°F) and do not refrigerate.

Inactive Ingredients



alcohol, anhydrous citric acid, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 6, flavor, glycerin, polysorbate 20, propylene glycol, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose, water


Questions?



1-877-881-5813


Principal Display Panel - 354 Ml Bottle



VICKS ®

PainQuil™ PM

PAIN RELIEVER + NIGHTTIME SLEEP-AID

Acetaminophen

Diphenhydramine HCl

STARTS WORKING FAST

FOR RELIEF OF:

ACHES | PAINS

HEADACHE | SORE THROAT

+ OCCASSIONAL SLEEPLESSNESS

HONEY FLAVORED

Alcohol 10%

12 FL OZ (354 ml)

350 - 350

350 - 350


* Please review the disclaimer below.