pain reliever

pain reliever
SPL v2
SPL
SPL Set ID 61e50135-a7c2-4a86-8a1a-d47b41d3f9d1
Route
oral
Published
Effective Date 2025-11-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (500 mg)
Inactive Ingredients
magnesium stearate potassium sorbate povidone k30 starch, corn water sodium starch glycolate type a

Identifiers & Packaging

Pill Appearance
Imprint: PAR500 Shape: capsule Color: white Size: 16 mm Score: 1
Marketing Status
otc monograph drug active Since 2025-11-07

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 500 mg


Medication Information

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.

Uses

temporarily relieves minor aches and pains due to:

  • the common cold
  • headache
  • backache
  • minor pain of arthritis
  • toothache
  • muscular aches
  • premenstrual and menstrual cramps
  • temporarily reduces fever
Purpose

Pain reliever/fever reducer

Directions

do not take more than directed (see overdose warning)

adults and children 12 years and over
  • take 2 caplets every 6 hours while symptoms last
  • do not take more than 6 caplets 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

store between 20-25°C (68-77°F)

Inactive Ingredients

magnesium stearate, potassium sorbate, povidone (K30), pregelatinized starch, purified water, sodium starch glycolate

Description

Acetaminophen 500 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
  • 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 aretaking the blood thinning drug warfarin

Section 50569-3

Ask a doctor before use if youhave 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 51945-4

Compare to the active ingredient

in Tylenol® Extra Strength

Pain Reliever



Acetaminophen 500 mg

Section 53414-9

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

Drug Facts

Acetaminophen 500 mg

Questions Or Comments?

1-800-373-6981


Structured Label Content

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.

Uses

temporarily relieves minor aches and pains due to:

  • the common cold
  • headache
  • backache
  • minor pain of arthritis
  • toothache
  • muscular aches
  • premenstrual and menstrual cramps
  • temporarily reduces fever
Purpose

Pain reliever/fever reducer

Directions

do not take more than directed (see overdose warning)

adults and children 12 years and over
  • take 2 caplets every 6 hours while symptoms last
  • do not take more than 6 caplets 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)

Inactive Ingredients (Inactive ingredients)

magnesium stearate, potassium sorbate, povidone (K30), pregelatinized starch, purified water, sodium starch glycolate

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
  • 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 aretaking the blood thinning drug warfarin

Section 50569-3 (50569-3)

Ask a doctor before use if youhave 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 51945-4 (51945-4)

Compare to the active ingredient

in Tylenol® Extra Strength

Pain Reliever



Acetaminophen 500 mg

Section 53414-9 (53414-9)

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

Drug Facts

Acetaminophen 500 mg

Questions Or Comments? (Questions or comments?)

1-800-373-6981


Advanced Ingredient Data


Raw Label Data

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