Acetaminophen Extra Stength Tablet

SPL v17

SPL

SPL Set ID 64696f65-415e-4ce1-a5b3-70662fbcb002

Route

ORAL

Published

Effective Date 2024-12-31

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Imprint: PH044 Shape: round Color: white Size: 12 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2006-01-10

Description

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 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

Section 51945-4

Acetaminophen 500mg

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING FROM BOTTLE.

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

more than 4000 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).

adult and children 12 years and over	take 2 tablets, every 4 to 6 hours while symptoms last do not take more than 6 tablets 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

Drug Facts

Other Information

store between 20-25 ⁰C (68-77 ⁰F)

Inactive Ingredients

povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid

Questions Or Comments?

(866)-562-2756 (Mon - Fri 8 AM to 4 PM EST)

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
redness or swelling is present
new symptoms occur

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: 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 don't notice any signs or symptoms.

Active Ingredient (in Each Tablet)

Acetaminophen 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

Section 51945-4 (51945-4)

Acetaminophen 500mg

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING FROM BOTTLE.

Purpose

Pain reliever/fever reducer

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

more than 4000 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).

adult and children 12 years and over	take 2 tablets, every 4 to 6 hours while symptoms last do not take more than 6 tablets 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

Drug Facts

Other Information (Other information)

store between 20-25 ⁰C (68-77 ⁰F)

Inactive Ingredients (Inactive ingredients)

povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid

Questions Or Comments? (Questions or comments?)

(866)-562-2756 (Mon - Fri 8 AM to 4 PM EST)

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
redness or swelling is present
new symptoms occur

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

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

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

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", "51945-4": "Acetaminophen 500mg TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING FROM BOTTLE.", "Purpose": "Pain reliever/fever reducer", "Warnings": "Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4000 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). adult and children 12 years and over take 2 tablets, every 4 to 6 hours while symptoms last do not take more than 6 tablets 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", "Other information": "store between 20-25 0 C (68-77 0 F)", "Inactive ingredients": "povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid", "Questions or comments?": "(866)-562-2756 (Mon - Fri 8 AM to 4 PM EST)", "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 redness or swelling is present new symptoms occur 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: 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 don't notice any signs or symptoms.", "Active ingredient (in each tablet)": "Acetaminophen 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: 2026-02-15T12:08:11.553611 · Updated: 2026-03-14T23:12:21.703136