340r cardinal health 70000 0092 acetaminophen tablets

340r cardinal health 70000 0092 acetaminophen tablets
SPL v4
SPL
SPL Set ID bdf8c511-ce25-0e30-e053-2a95a90a33f6
Route
oral
Published
Effective Date 2021-04-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (325 mg)
Inactive Ingredients
starch, corn sodium starch glycolate type a potato povidone stearic acid

Identifiers & Packaging

Pill Appearance
Imprint: TCL;340 Shape: round Color: white Size: 10 mm Score: 2
Marketing Status
otc monograph drug active Since 2021-05-05

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.

Active Ingredient

Active ingredient (in each tablet)

Acetaminophen 325 mg

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

adults and children 12 years and over

  • take 2 tablets (650 mg) every 4 to 6 hours while symptoms last
  • do not take more than 10 tablets (3,250 mg) 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 (325 mg) every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets (1,625 mg) in 24 hours
  • do not use for more than 5 days unless directed by a doctor

children under 6 years

ask a doctor

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
Description

Active ingredient (in each tablet) Acetaminophen 325 mg

Section 50565-1

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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 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 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 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


Structured Label Content

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.

Active Ingredient (55106-9)

Active ingredient (in each tablet)

Acetaminophen 325 mg

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

adults and children 12 years and over

  • take 2 tablets (650 mg) every 4 to 6 hours while symptoms last
  • do not take more than 10 tablets (3,250 mg) 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 (325 mg) every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets (1,625 mg) in 24 hours
  • do not use for more than 5 days unless directed by a doctor

children under 6 years

ask a doctor

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
Section 50565-1 (50565-1)

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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 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 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 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


Advanced Ingredient Data


Raw Label Data

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