acetaminophen caplets 500 mg dye free

acetaminophen caplets 500 mg dye free
SPL v1
SPL
SPL Set ID 42c4f0b2-6483-0f3c-e063-6294a90a140f
Route
oral
Published
Effective Date 2023-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (500 mg)
Inactive Ingredients
povidone sodium starch glycolate type a corn stearic acid starch, corn hypromelloses mineral oil

Identifiers & Packaging

Pill Appearance
Imprint: TCL479 Shape: capsule Color: white Size: 18 mm Score: 1
Marketing Status
otc monograph drug active Since 2024-11-01
Description

Active ingredient (in each caplet) Acetaminophen 500 mg

Medication Information

Warnings and Precautions

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.

Active Ingredient

Active ingredient (in each caplet)

Acetaminophen 500 mg

Indications and Usage

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

Dosage and Administration

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 unless directed by a doctor
children under 12 years

ask a doctor

Description

Active ingredient (in each caplet) Acetaminophen 500 mg

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 51727-6

Inactive ingredients

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

***may contain this ingredient

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.

Section 55105-1

Purpose

Pain reliever/fever reducer

Section 60561-8

Other information

  • SODIUM FREE
  • store between 20-25°C (68-77°F) excursions permitted between 15-30°C (59-86°F)
  • use by expiration date on package

Structured Label Content

Warnings and Precautions (34071-1)

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.

Active Ingredient (55106-9)

Active ingredient (in each caplet)

Acetaminophen 500 mg

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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 unless directed by a doctor
children under 12 years

ask a doctor

Section 34088-5 (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 (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 51727-6 (51727-6)

Inactive ingredients

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

***may contain this ingredient

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.

Section 55105-1 (55105-1)

Purpose

Pain reliever/fever reducer

Section 60561-8 (60561-8)

Other information

  • SODIUM FREE
  • store between 20-25°C (68-77°F) excursions permitted between 15-30°C (59-86°F)
  • use by expiration date on package

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:55.924662 · Updated: 2026-03-14T23:13:25.872506