SPL v1
SPL
SPL Set ID 34157f6a-3031-4388-e063-6394a90a670f
Route
ORAL
Published
Effective Date 2025-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Magnesium Stearate Starch, Corn Povidone

Identifiers & Packaging

Pill Appearance
Imprint: A500 Shape: round Color: white Size: 5 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-15

Description

Acetaminophen 500 mg

Purpose

Pain Reliever/Fever Reducer


Medication Information

Purpose

Pain Reliever/Fever Reducer

Description

Acetaminophen 500 mg

Uses

To reduce fever and for the temporary relief of minor aches and pains due to:

•headache

•muscular aches

•backache

•minor pain of arthritis

•the common cold

•toothache

•premenstrual and menstrual cramps.

•Temporarily reduces fever.

Section 51945-4

Warnings

Liver warning:

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • 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.

Do not use

  • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if the user has ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if the user has

has liver disease

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

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.

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

Keep out of reach of children.

Overdose Warning:

Taking more than the recommended dose (overdose) may cause liver damage. 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.

Other Information

store at 20° to 25°C (68° to 77°F)

Inactive Ingredients:

Gelatinized starch, magnesium stearate, povidone

Questions Or Comments?

Call toll-free 1-877-225-6999

Manufactured for

AARNA USA INC.

Leland, NC 28451

* This product is not manufactured or distributed by Johnson and Johnson, consumer inc., distributor of regular Tylenol Tablets.

Active Ingredient (in Each Tablet)

Acetaminophen 500 mg

Directions Do Not Take More Than Directed (see Overdose Warning)

adults & 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 use for more than 10 days unless directed by a doctor

children under 12 years

  • ask a doctor

Structured Label Content

Uses (USES)

To reduce fever and for the temporary relief of minor aches and pains due to:

•headache

•muscular aches

•backache

•minor pain of arthritis

•the common cold

•toothache

•premenstrual and menstrual cramps.

•Temporarily reduces fever.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

Pain Reliever/Fever Reducer

Warnings (WARNINGS)

Liver warning:

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • 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.

Do not use

  • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if the user has ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if the user has

has liver disease

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

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.

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

Keep out of reach of children.

Overdose Warning:

Taking more than the recommended dose (overdose) may cause liver damage. 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.

Other Information (OTHER INFORMATION)

store at 20° to 25°C (68° to 77°F)

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Gelatinized starch, magnesium stearate, povidone

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call toll-free 1-877-225-6999

Manufactured for

AARNA USA INC.

Leland, NC 28451

* This product is not manufactured or distributed by Johnson and Johnson, consumer inc., distributor of regular Tylenol Tablets.

Active Ingredient (in Each Tablet) (ACTIVE INGREDIENT (IN EACH TABLET))

Acetaminophen 500 mg

Directions Do Not Take More Than Directed (see Overdose Warning) (DIRECTIONS - DO NOT TAKE MORE THAN DIRECTED (SEE OVERDOSE WARNING))

adults & 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 use for more than 10 days unless directed by a doctor

children under 12 years

  • ask a doctor

Advanced Ingredient Data


Raw Label Data

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