479r Walg Acetaminophen Tablets 500 Mg Dye Free

SPL v2

SPL

SPL Set ID 3f9f1740-9e8b-6a2d-e063-6294a90a67cb

Route

ORAL

Published

Effective Date 2025-12-06

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg)

Inactive Ingredients

Stearic Acid Hypromellose, Unspecified Starch, Corn Povidone Sodium Starch Glycolate Type A Corn Mineral Oil

Identifiers & Packaging

Pill Appearance

Imprint: TCL479 Shape: oval Color: white Size: 18 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-12-15

Description

Purpose

Purpose Pain reliever/fever reducer

Medication Information

Purpose

Purpose

Pain reliever/fever reducer

Description

Uses

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 34088-5

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.

Section 50565-1

Keep out of reach of children.

Section 50566-9

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.

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 50570-1

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

Section 51945-4

Section 53413-1

Questions or comments? Call 1-877-290-4008

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

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 take for more than 10 days
children under 12 years	ask a doctor

Drug Facts

Active Ingredient

Active ingredient (in each caplet)

Acetaminophen 500 mg

Other Information

Other information

SODIUM FREE
store between 20-25℃ (68-77℉) excursions permitted between 15-30℃ (59-86℉)
use by expiration date on package

Inactive Ingredients

Inactive ingredients hypromellose, mineral oil, povidone, pregelatinized starch, sodium starch glycolate***, stearic acid

***may contain this ingredient

Structured Label Content

Uses

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 34088-5 (34088-5)

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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.

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 50570-1 (50570-1)

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? Call 1-877-290-4008

Section 53414-9 (53414-9)

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

Purpose

Purpose

Pain reliever/fever reducer

Warnings

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

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 take for more than 10 days
children under 12 years	ask a doctor

Drug Facts

Active Ingredient (Active ingredient)

Active ingredient (in each caplet)

Acetaminophen 500 mg

Other Information (Other information)

Other information

SODIUM FREE
store between 20-25℃ (68-77℉) excursions permitted between 15-30℃ (59-86℉)
use by expiration date on package

Inactive Ingredients (Inactive ingredients)

Inactive ingredients hypromellose, mineral oil, povidone, pregelatinized starch, sodium starch glycolate***, stearic acid

***may contain this ingredient

Advanced Ingredient Data

[{"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "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": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "SODIUM STARCH GLYCOLATE TYPE A CORN", "unii": "AG9B65PV6B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "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", "34088-5": "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.", "50565-1": "Keep out of reach of children.", "50566-9": "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.", "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", "50570-1": "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", "53413-1": "Questions or comments? Call 1-877-290-4008", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "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": "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 take for more than 10 days children under 12 years ask a doctor", "Drug Facts": "-", "Active ingredient": "Active ingredient (in each caplet) Acetaminophen 500 mg", "Other information": "Other information SODIUM FREE store between 20-25℃ (68-77℉) excursions permitted between 15-30℃ (59-86℉) use by expiration date on package", "Inactive ingredients": "Inactive ingredients hypromellose, mineral oil, povidone, pregelatinized starch, sodium starch glycolate***, stearic acid ***may contain this ingredient"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:39.787835 · Updated: 2026-03-14T23:11:22.461750