Acetaminophen Tabs 8250

Acetaminophen Tabs 8250
SPL v6
SPL
SPL Set ID 0f0daf9c-db70-405e-8d47-c1606b2843fd
Route
ORAL
Published
Effective Date 2025-11-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Starch, Corn Stearic Acid Povidone K30 Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Pill Appearance
Imprint: 54;27 Shape: round Color: white Size: 12 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-09-12

Description

Active Ingredient (in each tablet) Acetaminophen 500 mg


Medication Information

Description

Active Ingredient (in each tablet) Acetaminophen 500 mg

Uses

Temporarily reduces fever and relieves minor aches and pains due to:

  • headache
  • muscular aches
  • the common cold
  • toothache
  • backache
  • minor pain of arthritis
  • premenstrual and menstrual cramps
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 42229-5

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

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
  • 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 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Pain reliever/ Fever reducer

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.

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 take for more than 10 days unless directed by a doctor

children under 12 years: ask a doctor

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
Drug Facts

Active Ingredient (in each tablet)

Acetaminophen 500 mg

Other Information

store in a dry place at 15° – 30°C (59° – 86°F).

Inactive Ingredients

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions Or Comments?

Call 1-800-231-4670

Principal Display Panel Unit Dose
Principal Display Panel Bingo Card

Structured Label Content

Uses

Temporarily reduces fever and relieves minor aches and pains due to:

  • headache
  • muscular aches
  • the common cold
  • toothache
  • backache
  • minor pain of arthritis
  • premenstrual and menstrual cramps
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 42229-5 (42229-5)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

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
  • 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 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

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.

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 take for more than 10 days unless directed by a doctor

children under 12 years: ask a doctor

Do Not Use (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
Drug Facts

Active Ingredient (in each tablet)

Acetaminophen 500 mg

Other Information

store in a dry place at 15° – 30°C (59° – 86°F).

Inactive Ingredients (Inactive ingredients)

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions Or Comments? (Questions or comments?)

Call 1-800-231-4670

Principal Display Panel Unit Dose (PRINCIPAL DISPLAY PANEL - UNIT DOSE)
Principal Display Panel Bingo Card (PRINCIPAL DISPLAY PANEL - BINGO CARD)

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)