342r 0363 0669 walgreens acetaminophen 500 mg 100s

342r 0363 0669 walgreens acetaminophen 500 mg 100s
SPL v4
SPL
SPL Set ID c25bfe92-0196-0489-e053-2995a90abea1
Route
oral
Published
Effective Date 2025-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (500 mg)
Inactive Ingredients
povidone stearic acid hypromellose, unspecified sodium starch glycolate type a potato sucralose carnauba wax fd&c red no. 40 polyethylene glycol, unspecified starch, corn titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: TCL342 Shape: round Color: red Size: 11 mm Score: 1
Marketing Status
otc monograph drug active Since 2021-10-13

Description

Active ingredient (in each tablet) 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.

Active Ingredient

Active ingredient

(in each tablet)


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 (see overdose warning)

adults and children 12 years and over:

  • take 2 tablets every 6 hours while symptoms last
  • do not take more than 6 tablets 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

Other Information

Other information

store between 20-25°C (68-77°F)

Description

Active ingredient (in each tablet) Acetaminophen 500 mg

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 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 carnauba wax, FD&C Red #40 aluminum lake, hypromellose, polyethylene glycol, povidone, pregelatinized

starch, sodium starch glycolate*, stearic acid, sucralose, titanium dioxide *may contain this ingredient

Section 51945-4

Section 53413-1

Questions and 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. 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.

Active Ingredient (55106-9)

Active ingredient

(in each tablet)


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 (see overdose warning)

adults and children 12 years and over:

  • take 2 tablets every 6 hours while symptoms last
  • do not take more than 6 tablets 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

Other Information (OTHER INFORMATION)

Other information

store between 20-25°C (68-77°F)

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 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 carnauba wax, FD&C Red #40 aluminum lake, hypromellose, polyethylene glycol, povidone, pregelatinized

starch, sodium starch glycolate*, stearic acid, sucralose, titanium dioxide *may contain this ingredient

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions and 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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