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Pain Reliever


Drug Facts


Active ingredient (in each caplet)

Acetaminophen USP 500 mg


Purpose

Pain reliever/fever reducer


Uses

  • temporarily relieves minor aches and pains due to:
  • the common cold
  • headache
  • backache
  • minor pain of arthritis
  • toothache
  • muscular aches
  • premenstrual and menstrual cramps
  • temporarily reduces fever

Warnings


Liver Warning

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

Allergy alert

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

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

  • skin reddening
  • blisters
  • rash

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.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver disease


OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin


Stop use and ask a doctor if

Stop use and ask a doctor if

These could be signs of a serious condition.

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.


Overdose warning

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

Directions

adults and children 12 years and overtake 2 caplets every 6 hours while symptoms lastdo not take more than 6 caplets in 24 hours, unless directed by a doctordo not use for more than 10 days unless directed by a doctor
children under 12 yearsask a doctor
  • do not take more than directed (see Overdose warning)

Other information

Other information

  • store between 20° to 25°C (68° to 77°F)

Inactive ingredients

Inactive ingredients povidone, pregelatinized starch (maize), stearic acid


OTC - QUESTIONS SECTION

Questions or comments? Call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)


SPL UNCLASSIFIED SECTION

**This product is not manufactured or distributed by JOHNSON & JOHNSON CONSUMER, INC., McNeil Consumer Healthcare Division, distributor of Tylenol® Extra Strength Caplets.


PDP/Package

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Compare to the Active Ingredient in Tylenol® Extra Strength Caplets**

Extra Strength Pain Reliever

Acetaminophen 500 mg Pain Reliever/Fever Reducer

[caplet image]

ACTUAL SIZE

24

Caplets

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