340r-tcl 49483-340 Apap 325 Mg

340r-tcl 49483-340 Apap 325 Mg
SPL v11
SPL
SPL Set ID 3f2eadf9-9bb3-437e-972d-232828ca9d34
Route
ORAL
Published
Effective Date 2024-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg)
Inactive Ingredients
Povidone Starch, Corn Sodium Starch Glycolate Type A Potato Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: TCL340 Shape: round Color: white Size: 10 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2011-12-15 Until 2026-09-30

Description

Active ingredient (in each tablet) Acetaminophen 325 mg


Medication Information

Warnings and Precautions

Warnings

Liver Warning: This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children.  Severe liver damage may occur if:

  • adult takes more than 4,000 mg of acetaminophen in 24 hours.
  • child takes more than 5 doses in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adult has 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:
    • 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 tablets every 4 to 6 hours while symptoms last
  • do not take more than 10 tablets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor

children 6 years to under 12 years

  • take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by a doctor

children under 6 years

ask a doctor

Description

Active ingredient (in each tablet) Acetaminophen 325 mg

Section 42229-5

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

Manufactured by: Time-Cap Labs, Inc.,

7 Michael Avenue, Farmingdale, NY 11735

340R 1022

Section 50565-1

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 do not notice any signs or symptoms.

Section 50566-9

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days in adults
  • pain gets worse or lasts more than 5 days in children under 12 years 
  • 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 the user  

is taking the blood thinning drug warfarin

Section 50569-3

Ask a doctor before use if the user has 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

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

*may contain this ingredient

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 tablet)

Acetaminophen 325 mg

Other Information

Other information

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

Structured Label Content

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 tablets every 4 to 6 hours while symptoms last
  • do not take more than 10 tablets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor

children 6 years to under 12 years

  • take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by a doctor

children under 6 years

ask a doctor

Warnings and Precautions (34071-1)

Warnings

Liver Warning: This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children.  Severe liver damage may occur if:

  • adult takes more than 4,000 mg of acetaminophen in 24 hours.
  • child takes more than 5 doses in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adult has 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)

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

Manufactured by: Time-Cap Labs, Inc.,

7 Michael Avenue, Farmingdale, NY 11735

340R 1022

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 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 50566-9 (50566-9)

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days in adults
  • pain gets worse or lasts more than 5 days in children under 12 years 
  • 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 the user  

is taking the blood thinning drug warfarin

Section 50569-3 (50569-3)

Ask a doctor before use if the user has 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

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

*may contain this ingredient

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 tablet)

Acetaminophen 325 mg

Other Information (OTHER INFORMATION)

Other information

  • SODIUM FREE
  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package
Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Advanced Ingredient Data


Raw Label Data

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