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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®.


HOW SUPPLIED

Acetaminophen Tablets 500 mg

Repackaged/Relabeled by:Bryant Ranch Prepack, Inc.Burbank, CA 91504

  • NDC: 71335-1536-1: 20 Tablets in a BOTTLE
  • NDC: 71335-1536-2: 15 Tablets in a BOTTLE
  • NDC: 71335-1536-3: 40 Tablets in a BOTTLE
  • NDC: 71335-1536-4: 100 Tablets in a BOTTLE
  • NDC: 71335-1536-5: 30 Tablets in a BOTTLE
  • NDC: 71335-1536-6: 45 Tablets in a BOTTLE
  • NDC: 71335-1536-7: 50 Tablets in a BOTTLE
  • NDC: 71335-1536-8: 60 Tablets in a BOTTLE
  • NDC: 71335-1536-9: 90 Tablets in a BOTTLE
  • NDC: 71335-1536-0: 250 Tablets in a BOTTLE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acetaminophen Tablets 500 mg