340r cvs 69842-968 acetaminophen 325mg tablets

340r cvs 69842-968 acetaminophen 325mg tablets
SPL v4
SPL
SPL Set ID bbc48c9e-7eb8-2c67-e053-2a95a90a8552
Route
oral
Published
Effective Date 2025-02-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: TCL340 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
otc monograph drug active Since 2021-04-10
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
  • muscular aches
  • backache
  • minor pain of arthritis
  • the common cold
  • toothache
  • 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 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 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 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 at 25°C (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. 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
  • muscular aches
  • backache
  • minor pain of arthritis
  • the common cold
  • toothache
  • 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

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 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 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 at 25°C (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: 2026-02-15T12:05:33.368634 · Updated: 2026-03-14T23:07:34.278056