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5427-Major


Drug Facts

Active Ingredient (in each tablet)

Acetaminophen 500 mg


OTC - PURPOSE SECTION

Purpose

Pain reliever/ Fever reducer


Uses

Temporarily reduces fever and relieves minor aches and pains due to:

  • headache
  • muscular aches
  • backache
  • minor pain of arthritis
  • the common cold
  • toothache
  • premenstrual and menstrual cramps

WARNINGS SECTION

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

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.

  • 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

OTC - DO NOT USE SECTION

  • 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


OTC - STOP USE SECTION

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.


OVERDOSAGE SECTION

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

adults and children 12 years and over:

• take 2 tablets every 6 hours while symptoms last

• do not take more than 6 tablets in 24 hours, unless directed by a doctor

• do not take for more than 10 days unless directed by a doctor

children under 12 years: ask a doctor

  • do not take more than directed (see overdose warning)

Other Information

store in a dry place at 15° – 30°C (59° – 86°F).


INACTIVE INGREDIENT SECTION

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid


SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by:

MAJOR® PHARMACEUTICALS Indianapolis, IN 46268

*This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Tylenol®.


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR

THIS LARGE SIZE PACKAGE FOR DISPENSING PURPOSE ONLY

See New Warnings Information and Directions

Acetaminophen Extra Strength Tablets

Aspirin Free

Extra Strenght Pain reliever

Compare to active ingredient in Extra Strength Tylenol®* Tablets

1000 tablets

500mg each