Leader™ Extra Strength Acetaminophen

SPL v9

SPL

SPL Set ID 01f6428d-259c-4f02-8c69-6130b897373e

Route

ORAL

Published

Effective Date 2019-07-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg)

Inactive Ingredients

Fd&c Red No. 40 Gelatin Glycerin Polyethylene Glycol 400 Potassium Hydroxide Povidone K30 Propylene Glycol Sodium Hydroxide Water Sorbitan Sorbitol Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 710 Shape: oval Color: red Size: 23 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-07-10

Description

Drug Facts

Purpose

Pain reliever/ fever reducer

Medication Information

Purpose

Pain reliever/ fever reducer

Description

Drug Facts

Uses

■ temporarily relieves minor aches and pains due to:

■ the common cold ■ headache ■ backache

■ minor pain of arthritis ■ toothache ■ muscular aches

■ premenstrual and menstrual cramps

■ temporarily reduces fever

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50566-9

■ 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 53413-1

Questions or Comments? 1-888-333-9792

Section 53414-9

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

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

■ 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.

Directions

do not take more than directed (see Overdose warning)

Adults and children 12 years and over	■ take 2 softgels every 6 hours while symptoms last ■ do not take more than 6 softgels 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

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

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.

Other Information

■ each softgel contains: sodium 7 mg

■ store between 15°-30°C (59°-86°F)

Inactive Ingredients

FD&C Red #40, gelatin, glycerin, polyethylene glycol 400,

potassium hydroxide, povidone, propylene glycol, purified

water, sodium hydroxide, sorbitol, sorbitol sorbitan solution

titanium dioxide

Principal Display Panel

Leader™ Extra Strength Acetaminophen

Compare to the active ingredient

in Tylenol® Extra Strength*

Liquid-Filled Capsules**

EXTRA STRENGTH

Acetaminophen USP 500mg

Pain Reliever; Fever reducer

Aspirin free

40 SOFTGELS**

**Liquid filled capsules

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY

SEAL UNDER CAP IS BROKEN OR MISSING

This product is not manufactured

or distributed by McNeil Consumer

Healthcare, owner of the

registered trademark Tylenol®

Extra Strength.

Distributed by: CARDINAL HEALTH

DUBLIN, OHIO 43017

Made in India

CIN 5546221

Active Ingredient (in Each Softgel)

Acetaminophen 500 mg

Structured Label Content

Uses

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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 53413-1 (53413-1)

Questions or Comments? 1-888-333-9792

Section 53414-9 (53414-9)

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

Purpose

Pain reliever/ fever reducer

Warnings

Directions

do not take more than directed (see Overdose warning)

Adults and children 12 years and over	■ take 2 softgels every 6 hours while symptoms last ■ do not take more than 6 softgels 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

Do Not Use (Do not use)

Overdose Warning (Overdose warning)

Other Information (Other information)

■ each softgel contains: sodium 7 mg

■ store between 15°-30°C (59°-86°F)

Inactive Ingredients (Inactive ingredients)

FD&C Red #40, gelatin, glycerin, polyethylene glycol 400,

potassium hydroxide, povidone, propylene glycol, purified

water, sodium hydroxide, sorbitol, sorbitol sorbitan solution

titanium dioxide

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Leader™ Extra Strength Acetaminophen

Compare to the active ingredient

in Tylenol® Extra Strength*

Liquid-Filled Capsules**

EXTRA STRENGTH

Acetaminophen USP 500mg

Pain Reliever; Fever reducer

Aspirin free

40 SOFTGELS**

**Liquid filled capsules

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY

SEAL UNDER CAP IS BROKEN OR MISSING

This product is not manufactured

or distributed by McNeil Consumer

Healthcare, owner of the

registered trademark Tylenol®

Extra Strength.

Distributed by: CARDINAL HEALTH

DUBLIN, OHIO 43017

Made in India

CIN 5546221

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Acetaminophen 500 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "■ temporarily relieves minor aches and pains due to: ■ the common cold ■ headache ■ backache ■ minor pain of arthritis ■ toothache ■ muscular aches ■ premenstrual and menstrual cramps ■ temporarily reduces fever", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "50566-9": "■ 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.", "50568-5": "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.", "50569-3": "Ask a doctor before use if you have liver disease", "53413-1": "Questions or Comments? 1-888-333-9792", "53414-9": "If pregnant or breast-feeding , ask a health professional before use.", "Purpose": "Pain reliever/ fever reducer", "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 ■ 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.", "Directions": "do not take more than directed (see Overdose warning ) Adults and children 12 years and over ■ take 2 softgels every 6 hours while symptoms last ■ do not take more than 6 softgels 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", "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", "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.", "Other information": "■ each softgel contains : sodium 7 mg ■ store between 15°-30°C (59°-86°F)", "Inactive ingredients": "FD&C Red #40, gelatin, glycerin, polyethylene glycol 400, potassium hydroxide, povidone, propylene glycol, purified water, sodium hydroxide, sorbitol, sorbitol sorbitan solution titanium dioxide", "PRINCIPAL DISPLAY PANEL": "Leader™ Extra Strength Acetaminophen Compare to the active ingredient in Tylenol® Extra Strength* Liquid-Filled Capsules** EXTRA STRENGTH Acetaminophen USP 500mg Pain Reliever; Fever reducer Aspirin free 40 SOFTGELS** **Liquid filled capsules TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Extra Strength. Distributed by: CARDINAL HEALTH DUBLIN, OHIO 43017 Made in India CIN 5546221", "Active ingredient (in each softgel)": "Acetaminophen 500 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:26.796482 · Updated: 2026-03-14T23:01:59.101977