341r walmart acetaminophen 500 mg tablets (49035-869)

341r walmart acetaminophen 500 mg tablets (49035-869)
SPL v3
SPL
SPL Set ID a354b24e-0913-829f-e053-2995a90ad407
Route
oral
Published
Effective Date 2023-02-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: TCL341 Shape: oval Color: white Size: 17 mm Score: 1
Marketing Status
otc monograph drug active Since 2020-06-01

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 8 caplets in 24 hours, which is the maximum daily amount
  • 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:

  • 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 caplets (1,000 mg) every 6 hours while symptoms last

- do not take more than 6 caplets (3,000 mg) in 24 hours, unless directed by a doctor

- do not use 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 50565-1

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away (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

  • symptoms do not improve
  • new symptoms occur
  • pain or fever persists or gets worse

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
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor
Section 51727-6

Inactive ingredients

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

*may contain this ingredient

Section 51945-4

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. Severe liver damage may occur if you take

  • more than 8 caplets in 24 hours, which is the maximum daily amount
  • 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:

  • 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 caplets (1,000 mg) every 6 hours while symptoms last

- do not take more than 6 caplets (3,000 mg) in 24 hours, unless directed by a doctor

- do not use more than 10 days unless directed by a doctor

children under 12 years:ask a doctor

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 right away (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

  • symptoms do not improve
  • new symptoms occur
  • pain or fever persists or gets worse

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
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor
Section 51727-6 (51727-6)

Inactive ingredients

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

*may contain this ingredient

Section 51945-4 (51945-4)

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)