Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 66244cdb-2680-4fa8-890d-32aefd490038
Route
ORAL
Published
Effective Date 2023-11-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: AZ;328 Shape: oval Color: white Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-28

Description

Acteminophen 500 mg


Medication Information

Warnings and Precautions

Liver Warning:This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4000 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.

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.

Ask a doctor before use if you haveliver disease

Ask a doctor or pharmacist before use if youare taking the blood thinning drug warfarin

Stop use and ask a doctor if:

  • Pain gets worse or lasts for more than 10 days
  • Fever gets worse or lasts for more than 3 days
  • New symptoms occur
  • Redness or swelling is present

These could be signs of a serious condition

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

Do not exceed recommended dosage.

Indications and Usage

For the temporary relief of minor aches and pains associated with: the common cold, headache, toothache, muscular aches, backache, minor pain from arthritis, premenstural and menstrual cramps

Temporarily reduces fever

Dosage and Administration

​Do not use more than directed (see overdose warnings)

Adults and children 12 years of age and older:

  • 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 more than 10 days unless directed by a doctor.

Children under 12 years of age: consult a doctor

Description

Acteminophen 500 mg

Section 50565-1

In case of accidental overdose, contact a doctor or 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 51727-6

Corn Starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Section 51945-4

Section 55105-1

Pain reliever / Fever reducer

Section 55106-9

Acteminophen 500 mg


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of minor aches and pains associated with: the common cold, headache, toothache, muscular aches, backache, minor pain from arthritis, premenstural and menstrual cramps

Temporarily reduces fever

Dosage and Administration (34068-7)

​Do not use more than directed (see overdose warnings)

Adults and children 12 years of age and older:

  • 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 more than 10 days unless directed by a doctor.

Children under 12 years of age: consult a doctor

Warnings and Precautions (34071-1)

Liver Warning:This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4000 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.

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.

Ask a doctor before use if you haveliver disease

Ask a doctor or pharmacist before use if youare taking the blood thinning drug warfarin

Stop use and ask a doctor if:

  • Pain gets worse or lasts for more than 10 days
  • Fever gets worse or lasts for more than 3 days
  • New symptoms occur
  • Redness or swelling is present

These could be signs of a serious condition

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

Do not exceed recommended dosage.

Section 50565-1 (50565-1)

In case of accidental overdose, contact a doctor or 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 51727-6 (51727-6)

Corn Starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Pain reliever / Fever reducer

Section 55106-9 (55106-9)

Acteminophen 500 mg


Advanced Ingredient Data


Raw Label Data

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