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  5. Label Information: Tylenol Pm Extra Strength

FDA Label for Tylenol Pm Extra Strength

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. LIVER WARNING
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. OVERDOSE WARNING
    13. DIRECTIONS
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS
    16. QUESTIONS OR COMMENTS?
    17. PRINCIPAL DISPLAY PANEL

Tylenol Pm Extra Strength Product Label

The following document was submitted to the FDA by the labeler of this product Johnson & Johnson Consumer 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

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 - Purpose



Active ingredient (in each 30 mL)Purpose
Acetaminophen 1,000 mgPain reliever
Diphenhydramine HCl 50 mgNighttime sleep aid

Uses



  • temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Liver Warning



This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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.
  • with any other product containing diphenhydramine, even one used on skin
  • in children under 12 years of age
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask A Doctor Before Use If You Have



  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • glaucoma

Ask A Doctor Or Pharmacist If You Are



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

When Using This Product



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

Stop Use And Ask A Doctor If



  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness
  • 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

    • 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.


Overdose Warning



In case of overdose, get medical help or contact a Poison Control Center right away. (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



  • do not take more than directed (see overdose warning)
  • mL = milliliter
  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
    • adults and children 12 years and over
    • take 30 mL in the dosing cup provided at bedtime
    • do not take more than 30 mL of this product in 24 hours
    children under 12 yearsdo not use

Other Information



  • each 30 mL contains: sodium 15 mg
  • store between 20-25°C (68-77°F)
  • do not use if neck band imprinted with "TYLENOL PM" or foil inner seal imprinted with "SAFETY SEAL®" is broken or missing

Inactive Ingredients



anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, sucrose


Questions Or Comments?



call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)


Principal Display Panel



NDC 50580-833-01

Extra Strength
TYLENOL®
PM

NEW

Acetaminophen Diphenhydramine HCl
Pain Reliever, Nighttime Sleep Aid
Non-habit forming

8 fl oz (240 mL)

Bedtime Berry

PRINCIPAL DISPLAY PANEL - tylenol 01

PRINCIPAL DISPLAY PANEL - tylenol 01


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