5427-major

5427-major
SPL v13
SPL
SPL Set ID c4f0f591-8501-4c6d-bf8e-ca3068ff65b5
Route
ORAL
Published
Effective Date 2025-04-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Starch, Corn Stearic Acid Povidone K30 Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Pill Appearance
Imprint: 54;27 Shape: round Color: white Size: 12 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2018-09-12 Until 2025-04-23

Description

Active Ingredient (in each tablet) Acetaminophen 500 mg

How Supplied

Product: 50090-5350 NDC: 50090-5350-1 42 TABLET in a BOTTLE


Medication Information

Warnings and Precautions

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: 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.

How Supplied

Product: 50090-5350

NDC: 50090-5350-1 42 TABLET in a BOTTLE

Description

Active Ingredient (in each tablet) Acetaminophen 500 mg

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
Section 34088-5

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.

Section 42229-5

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®.

Section 50565-1

Keep out of reach of children.

Section 50566-9

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 
  • new symptoms occur 
  • redness or swelling is present

These could be signs of a serious condition.

Section 50568-5

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

Section 50569-3

Ask a doctor before use if you have liver disease

Section 50570-1
  • 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
Section 51727-6

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Section 53414-9

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

Section 55105-1

Purpose

Pain reliever/ Fever reducer

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

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

Drug Facts

Active Ingredient (in each tablet)

Acetaminophen 500 mg

Acetaminophen
Other Information

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

Questions Or Comments?

Call 1-800-231-4670


Structured Label Content

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 and Precautions (34071-1)

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: 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.

Section 34088-5 (34088-5)

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.

Section 42229-5 (42229-5)

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®.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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 
  • new symptoms occur 
  • redness or swelling is present

These could be signs of a serious condition.

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

Ask a doctor before use if you have liver disease

Section 50570-1 (50570-1)
  • 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
Section 51727-6 (51727-6)

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Pain reliever/ Fever reducer

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

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

Drug Facts

Active Ingredient (in each tablet)

Acetaminophen 500 mg

How Supplied (HOW SUPPLIED)

Product: 50090-5350

NDC: 50090-5350-1 42 TABLET in a BOTTLE

Acetaminophen
Other Information

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

Questions Or Comments? (Questions or comments?)

Call 1-800-231-4670


Advanced Ingredient Data


Raw Label Data

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