Pain Reliever

SPL v3

SPL

SPL Set ID e5f9def4-4cf5-4e06-e053-2995a90a07ea

Route

ORAL

Published

Effective Date 2022-03-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg)

Inactive Ingredients

Starch, Corn Povidone K30 Palmitostearic Acid

Identifiers & Packaging

Pill Appearance

Imprint: N79 Shape: oval Color: white Size: 18 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-03-04

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

Section 42229-5

**This product is not manufactured or distributed by JOHNSON & JOHNSON CONSUMER, INC., McNeil Consumer Healthcare Division, distributor of Tylenol® Extra Strength Caplets.

Section 50565-1

Keep out of reach of children.

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?

Call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

Section 53414-9

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

Directions

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

Pdp/package

[caduceus]

Compare to the Active

Ingredient in Tylenol®

Extra Strength Caplets**

Extra Strength

Pain Reliever

Acetaminophen 500 mg

Pain Reliever/Fever Reducer

[caplet image]

ACTUAL SIZE

Caplets

[Lil' Drug Store logo]

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: 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

Overdose Warning

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

Other information

store between 20° to 25°C (68° to 77°F)

Inactive Ingredients

Inactive ingredients povidone, pregelatinized starch (maize), stearic acid

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.

Active Ingredient (in Each Caplet)

Acetaminophen USP 500 mg

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 42229-5 (42229-5)

**This product is not manufactured or distributed by JOHNSON & JOHNSON CONSUMER, INC., McNeil Consumer Healthcare Division, distributor of Tylenol® Extra Strength Caplets.

Section 50565-1 (50565-1)

Keep out of reach of children.

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?

Call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

Section 53414-9 (53414-9)

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

Purpose

Pain reliever/fever reducer

Directions

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)

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

Pdp/package (PDP/Package)

[caduceus]

Compare to the Active

Ingredient in Tylenol®

Extra Strength Caplets**

Extra Strength

Pain Reliever

Acetaminophen 500 mg

Pain Reliever/Fever Reducer

[caplet image]

ACTUAL SIZE

Caplets

[Lil' Drug Store logo]

Allergy Alert (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: 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

Overdose Warning (Overdose warning)

Other Information (Other information)

Other information

store between 20° to 25°C (68° to 77°F)

Inactive Ingredients (Inactive ingredients)

Inactive ingredients povidone, pregelatinized starch (maize), stearic acid

Stop Use and Ask A Doctor If (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.

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

Acetaminophen USP 500 mg

Advanced Ingredient Data

[{"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE K30", "unii": "U725QWY32X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PALMITOSTEARIC ACID", "unii": "Q8Y7S3B85M", "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", "42229-5": "**This product is not manufactured or distributed by JOHNSON & JOHNSON CONSUMER, INC., McNeil Consumer Healthcare Division, distributor of Tylenol® Extra Strength Caplets.", "50565-1": "Keep out of reach of children.", "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? Call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)", "53414-9": "If pregnant or breast-feeding , ask a health professional before use.", "Purpose": "Pain reliever/fever reducer", "Directions": "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", "PDP/Package": "[caduceus] Compare to the Active Ingredient in Tylenol® Extra Strength Caplets** Extra Strength Pain Reliever Acetaminophen 500 mg Pain Reliever/Fever Reducer [caplet image] ACTUAL SIZE 24 Caplets [Lil' Drug Store logo]", "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: 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", "Overdose warning": "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": "Other information store between 20° to 25°C (68° to 77°F)", "Inactive ingredients": "Inactive ingredients povidone, pregelatinized starch (maize), stearic acid", "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.", "Active ingredient (in each caplet)": "Acetaminophen USP 500 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:11.035479 · Updated: 2026-03-14T23:06:36.654428