Compare To Active Ingredient In Tylenol®

Compare To Active Ingredient In Tylenol®
SPL v4
SPL
SPL Set ID bd5e6804-4df4-4a65-92e4-faa3a0f7c005
Route
ORAL
Published
Effective Date 2025-07-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg)
Inactive Ingredients
Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone Starch, Corn Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-09

Description

Active Ingredient (in each tablet)                           Purpose Acetaminophen USP, 325 mg.................................Pain Reliever/Fever Reducer


Medication Information

Description

Active Ingredient (in each tablet)                           Purpose Acetaminophen USP, 325 mg.................................Pain Reliever/Fever Reducer

Uses

To reduce fever and for the temporary relief of minor aches and

pains due to:

  • headache 
  • muscular aches
  • backache
  • minor pain from arthritis 
  • the common cold
  • toothache
  • premenstrual and menstrual cramps
  • temporarily reduces fever.
Section 50565-1

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). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50568-5

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

Stop use and ask a doctor if

• pain gets worse or lasts more than 10 days in adults and children.

• pain gets worse or lasts more than 5 days in children under 12 years.

• 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 50569-3

Ask a doctor before use if you have liver disease.

Section 53413-1

Questions and Comments? Call 1-844-474-7464

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Made in India

Mfg. Lic. No.: G/25/2258

Issued: 06/2025 (S-065)

Issued: 07/2025 (S-069-00)

This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, owner of the registered trademark Tylenol ® Regular strength.

Section 53414-9

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

Section 55105-1

Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if

  • adult takes more than 10 tablets in 24 hours, which is the maximum daily amount 
  • child takes more than 5 tablets in 24 hours 
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product

Directions

Do not take more than directed

Adults and 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 take for more than 10 days unless directed by a doctor

Children 6 years to under 12 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

Children under 6 years:

ask a doctor

Other Information

  • SODIUM FREE
  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • see end panel for lot number and expiration date.
Do Not Use
  • 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.
Inactive Ingredients

Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide.

Package Label.principal Display Panel

Acetaminophen

325 mg

100 Film Coated Tablets

Do Not Use If Imprinted Safety Seal Under Cap Is Broken Or Missing.

Active Ingredient (in each tablet)                           Purpose

Acetaminophen USP, 325 mg.................................Pain Reliever/Fever Reducer


Structured Label Content

Uses

To reduce fever and for the temporary relief of minor aches and

pains due to:

  • headache 
  • muscular aches
  • backache
  • minor pain from arthritis 
  • the common cold
  • toothache
  • premenstrual and menstrual cramps
  • temporarily reduces fever.
Section 50565-1 (50565-1)

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). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50568-5 (50568-5)

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

Stop use and ask a doctor if

• pain gets worse or lasts more than 10 days in adults and children.

• pain gets worse or lasts more than 5 days in children under 12 years.

• 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 50569-3 (50569-3)

Ask a doctor before use if you have liver disease.

Section 53413-1 (53413-1)

Questions and Comments? Call 1-844-474-7464

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Made in India

Mfg. Lic. No.: G/25/2258

Issued: 06/2025 (S-065)

Issued: 07/2025 (S-069-00)

This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, owner of the registered trademark Tylenol ® Regular strength.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if

  • adult takes more than 10 tablets in 24 hours, which is the maximum daily amount 
  • child takes more than 5 tablets in 24 hours 
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product

Directions

Do not take more than directed

Adults and 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 take for more than 10 days unless directed by a doctor

Children 6 years to under 12 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

Children under 6 years:

ask a doctor

Other Information

  • SODIUM FREE
  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • see end panel for lot number and expiration date.
Do Not Use (Do not use)
  • 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.
Inactive Ingredients

Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Acetaminophen

325 mg

100 Film Coated Tablets

Do Not Use If Imprinted Safety Seal Under Cap Is Broken Or Missing. (DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.)

Active Ingredient (in each tablet)                           Purpose

Acetaminophen USP, 325 mg.................................Pain Reliever/Fever Reducer


Advanced Ingredient Data


Raw Label Data

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