Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID c6f41729-840e-0db5-e053-2a95a90aea7e
Route
ORAL
Published
Effective Date 2019-01-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg)
Inactive Ingredients
Starch, Corn Povidone Sodium Starch Glycolate Type A Corn Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: AZ;010 Shape: round Color: white Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2021-07-12 Until 2026-03-31

Description

Acetaminophen 325mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer



Description

Acetaminophen 325mg

Uses

temporary relief of minor aches and pains associated with:

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

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

  • adult takes more than 4,000 mg in 24 hours
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 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

Adults and children 12 years of age and over: Take 2 tablets every 4 to 6 hours.

Do not take more than 10 tablets in 24 hours.

Children 6-11 years of age: Take 1 tablet every 4 to 6 hours as needed.

Do not take more than 5 tablets in 24 hours.

Children under 6 years of age: Do not use this regular strenght product. This will provide more than the recommended dose (overdose) and could cause serious health problems.

Do Not Use
  • if you are allergic to acetamiophen
  • with other products containing acetaminophen (prescription or nonprescription).

If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Other Information
  • store at room temperature
  • do not use if imprinted safety seal under cap is broken or missing
Inactive Ingredients

corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Principal Display Panel

Stop Use and Ask A Doctor If
  • symptoms do not improve
  • pain gets worse or lasts for more than 10 days
  • pain gets worse or lasts more than 5 days in children under 12 years
  • fever gets worse or lasts for more than 3 days
  • new symptoms occur
  • redness or swelling is present
  • a rare sensitivity reaction occurs
  • You may report side effects to 1-888-952-0050
If Pregnant Or Breast Feeding

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

Keep Out of Reach of Children

Keep out of reach of children. In  case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. 

Active Ingredient (in Each Tablet)

Acetaminophen 325mg

Ask A Doctor Before Use If User Has

liver disease.

Ask A Doctor Or Pharmacist Before Use If

the user is taking the blood thinning drug warfarin


Structured Label Content

Uses

temporary relief of minor aches and pains associated with:

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

Pain reliever/fever reducer



Warnings

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

  • adult takes more than 4,000 mg in 24 hours
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 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

Adults and children 12 years of age and over: Take 2 tablets every 4 to 6 hours.

Do not take more than 10 tablets in 24 hours.

Children 6-11 years of age: Take 1 tablet every 4 to 6 hours as needed.

Do not take more than 5 tablets in 24 hours.

Children under 6 years of age: Do not use this regular strenght product. This will provide more than the recommended dose (overdose) and could cause serious health problems.

Do Not Use (Do not use)
  • if you are allergic to acetamiophen
  • with other products containing acetaminophen (prescription or nonprescription).

If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Other Information (Other information)
  • store at room temperature
  • do not use if imprinted safety seal under cap is broken or missing
Inactive Ingredients (Inactive ingredients)

corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • symptoms do not improve
  • pain gets worse or lasts for more than 10 days
  • pain gets worse or lasts more than 5 days in children under 12 years
  • fever gets worse or lasts for more than 3 days
  • new symptoms occur
  • redness or swelling is present
  • a rare sensitivity reaction occurs
  • You may report side effects to 1-888-952-0050
If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

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

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children. In  case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. 

Active Ingredient (in Each Tablet) (Active Ingredient (in each tablet))

Acetaminophen 325mg

Ask A Doctor Before Use If User Has (Ask a doctor before use if user has)

liver disease.

Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)

the user is taking the blood thinning drug warfarin


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)