Extra Strength

SPL v5

SPL

SPL Set ID 08f57305-0c4b-96b1-e063-6394a90a77df

Route

ORAL

Published

Effective Date 2024-08-02

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg)

Inactive Ingredients

Stearic Acid Starch, Corn Povidone Hypromelloses Polyethylene Glycol, Unspecified Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Pill Appearance

Imprint: G;551 Shape: oval Color: white Size: 17 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-08-02

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

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

Directions

■ do not take more than directed (see overdose warning)

adults and children 12 years and over

■ take 2 caplets every 6 hours while symptoms last

■ do not take more than 6 caplets 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

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

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

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

■ see end panel for lot number and expiration date

Inactive Ingredients

hydroxypropyl methyl cellulose, polyethylene glycol, povidone k-30, pregelatinized starch, sodium starch glycolate, stearic acid

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

Keep Out of Reach of Children

Keep out of reach of children

If Pregnant Or Breast Feeding,

ask a health professional before use

Active Ingredient (in Each Caplet)

Acetaminophen USP, 500 mg

Ask A Doctor Before Use If You Have

liver disease

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

Warnings

Directions

■ do not take more than directed (see overdose warning)

adults and children 12 years and over

■ take 2 caplets every 6 hours while symptoms last

■ do not take more than 6 caplets 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)

■ 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: (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

Overdose Warning (Overdose warning)

Other Information (Other information)

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

■ see end panel for lot number and expiration date

Inactive Ingredients (Inactive ingredients)

hydroxypropyl methyl cellulose, polyethylene glycol, povidone k-30, pregelatinized starch, sodium starch glycolate, stearic acid

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 (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

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

Keep out of reach of children

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Acetaminophen USP, 500 mg

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

liver disease

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

[{"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

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", "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", "Directions": "■ do not take more than directed (see overdose warning) adults and children 12 years and over ■ take 2 caplets every 6 hours while symptoms last ■ do not take more than 6 caplets 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", "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", "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": "■ store between 20-25°C (68-77°F). See USP Controlled Room Temperature. ■ see end panel for lot number and expiration date", "Inactive ingredients": "hydroxypropyl methyl cellulose, polyethylene glycol, povidone k-30, pregelatinized starch, sodium starch glycolate, stearic acid", "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", "Keep out of reach of children": "Keep out of reach of children", "If pregnant or breast-feeding,": "ask a health professional before use", "Active ingredient (in each caplet)": "Acetaminophen USP, 500 mg", "Ask a doctor before use if you have": "liver disease", "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: 2026-02-15T12:07:48.999958 · Updated: 2026-03-14T23:11:40.308391