Pain Reliever

SPL v5

SPL

SPL Set ID e467b78e-9f23-5563-e053-2a95a90a586e

Route

ORAL

Published

Effective Date 2023-03-03

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg)

Inactive Ingredients

Sucralose Polyvinyl Alcohol, Unspecified Talc Titanium Dioxide Starch, Corn Fd&c Yellow No. 6 Lecithin, Soybean Polyethylene Glycol, Unspecified Povidone K30 Fd&c Red No. 40 Stearic Acid

Identifiers & Packaging

Pill Appearance

Imprint: L;1 Shape: round Color: red Size: 11 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-03-03

Description

Acetaminophen USP, 500 mg

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen USP, 500 mg

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

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 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

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.

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

Other Information

■ store at 20°-25°C (68°-77°F). See USP Controlled Room Temperature

■ do not use if imprinted safety seal under cap is broken or missing

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.

Inactive Ingredients

FD&C red no. 40, FD&C yellow no. 6, lecithin, polyethylene glycol, povidone k-30, polyvinyl alcohol, pregelatinized starch, stearic acid, sucralose, talc, titanium dioxide.

Questions Or Comments?

call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.

Principal Display Panel

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 the Reach of Children.

Keep out of the reach of children.

Ask A Doctor Before Use If You Have

liver disease

Active Ingredient (in Each Coated Tablet)

Acetaminophen USP, 500 mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin

Structured Label Content

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

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 more than 10 days unless directed by a doctor

children under 12 years

■ ask a doctor

Do Not Use (Do not use)

Allergy Alert: (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.

Liver Warning: (Liver warning:)

Other Information (Other information)

■ store at 20°-25°C (68°-77°F). See USP Controlled Room Temperature

■ do not use if imprinted safety seal under cap is broken or missing

Overdose Warning: (Overdose warning:)

Inactive Ingredients (Inactive ingredients)

FD&C red no. 40, FD&C yellow no. 6, lecithin, polyethylene glycol, povidone k-30, polyvinyl alcohol, pregelatinized starch, stearic acid, sucralose, talc, titanium dioxide.

Questions Or Comments? (Questions or comments?)

call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.

Principal Display Panel

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of the Reach of Children. (Keep out of the reach of children.)

Keep out of the reach of children.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver disease

Active Ingredient (in Each Coated Tablet) (Active ingredient (in each coated tablet))

Acetaminophen USP, 500 mg

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin

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", "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 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", "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.", "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", "Other information": "■ store at 20°-25°C (68°-77°F). See USP Controlled Room Temperature ■ do not use if imprinted safety seal under cap is broken or missing", "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.", "Inactive ingredients": "FD&C red no. 40, FD&C yellow no. 6, lecithin, polyethylene glycol, povidone k-30, polyvinyl alcohol, pregelatinized starch, stearic acid, sucralose, talc, titanium dioxide.", "Questions or comments?": "call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.", "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 the reach of children.": "Keep out of the reach of children.", "Ask a doctor before use if you have": "liver disease", "Active ingredient (in each coated tablet)": "Acetaminophen USP, 500 mg", "Ask a doctor or pharmacist before use if you are": "taking the blood thinning drug warfarin"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:49.971770 · Updated: 2026-03-14T23:11:42.520832