SPL v1
SPL
SPL Set ID 33f0e822-28af-9bb2-e063-6294a90a5175
Route
ORAL
Published
Effective Date 2025-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg)
Inactive Ingredients
Starch, Corn Povidone Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Imprint: A325 Shape: round Color: white Size: 4 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-15

Description

Active ingredient (in each tablet) Acetaminophen 325 mg


Medication Information

Warnings and Precautions

Warnings

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 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
  • is a child with pain of arthritis

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 (for adults) or 5 days (for children)
  • 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.

Indications and Usage

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.

Description

Active ingredient (in each tablet) Acetaminophen 325 mg

Section 34088-5



adults & children

12 years and over

  • take 2 tablets every 4 to 6 hours while symptoms last
  • do not take more than 10 tablets in 24 hours
  • do not use for more than 10 days unless directed by a doctor

children 6-11 years

  • take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by a doctor

child under 6 years

ask a doctor

Section 51727-6

Inactive Ingredients:

  • Gelatinized starch, magnesium stearate, povidone
Section 51945-4

Section 53413-1

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.

Section 55105-1

Purpose

Pain Reliever/Fever Reducer

Section 55106-9

Active ingredient (in each tablet)

Acetaminophen 325 mg

Section 60561-8

Other information

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

Structured Label Content

Indications and Usage (34067-9)

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.

Warnings and Precautions (34071-1)

Warnings

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 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
  • is a child with pain of arthritis

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 (for adults) or 5 days (for children)
  • 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.

Section 34088-5 (34088-5)



adults & children

12 years and over

  • take 2 tablets every 4 to 6 hours while symptoms last
  • do not take more than 10 tablets in 24 hours
  • do not use for more than 10 days unless directed by a doctor

children 6-11 years

  • take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by a doctor

child under 6 years

ask a doctor

Section 51727-6 (51727-6)

Inactive Ingredients:

  • Gelatinized starch, magnesium stearate, povidone
Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

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.

Section 55105-1 (55105-1)

Purpose

Pain Reliever/Fever Reducer

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Acetaminophen 325 mg

Section 60561-8 (60561-8)

Other information

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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)