Acetaminophen Caplets 8409

Acetaminophen Caplets 8409
SPL v14
SPL
SPL Set ID 7fae4caf-a8aa-442e-97ee-0465577bdb87
Route
ORAL
Published
Effective Date 2024-08-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Hypromelloses Mineral Oil Povidone Starch, Corn Stearic Acid Titanium Dioxide Sodium Starch Glycolate Type A Corn

Identifiers & Packaging

Pill Appearance
Imprint: TCL341 Shape: oval Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2011-07-18 Until 2026-04-30

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.

Indications and Usage

Uses

  • temporarily relieves minor aches and pains due to:

          • headache

          • the common cold

          • 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 use 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 42229-5

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

Section 50565-1

Keep out of reach of children.

Overdose warning:  In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9

Stop using and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or last 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 glycloate*, stearic acid, titanium dioxide

*may contain this ingredient

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

Section 53413-1

Manufactured by:

Time-Cap Labs, Inc

7 Michael Avenue

Farmingdale, NY 11735

341R 0922

Section 53414-9

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

Section 55105-1

Purpose

Pain reliever/fever reducer

Section 55106-9

Active ingredient (in each caplet)

Acetaminophen 500 mg

Principal Display Panel Unit Dose
Principal Display Panel Bingo Card

Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves minor aches and pains due to:

          • headache

          • the common cold

          • 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 use for more than 10 days unless directed by a doctor

children under 12 years

ask a doctor

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.

Section 42229-5 (42229-5)

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Overdose warning:  In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9 (50566-9)

Stop using and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or last 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 glycloate*, stearic acid, titanium dioxide

*may contain this ingredient

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

Section 53413-1 (53413-1)

Manufactured by:

Time-Cap Labs, Inc

7 Michael Avenue

Farmingdale, NY 11735

341R 0922

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 55106-9 (55106-9)

Active ingredient (in each caplet)

Acetaminophen 500 mg

Principal Display Panel Unit Dose (PRINCIPAL DISPLAY PANEL - UNIT DOSE)
Principal Display Panel Bingo Card (PRINCIPAL DISPLAY PANEL - BINGO CARD)

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)