Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 61c6d281-e59b-4277-bbce-f71c12c2a56d
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 Active Since 2016-04-15

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. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours

for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if

  • adult takes more than 4,000mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours, which is the maximum daily amount
  • 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
  • do not take more than directed (see overdose warning)

Adults and children 12 years and over:

  • Take 2 tablets every 4 to 6 hours while symptoms last
  • Do not take more than 10 tablets in 24 hours, unless directed by a doctor
  • Do not use for more than 10 days unless directed by a doctor

Children 6-11 years of age:

  • Take 1 tablet every 4 to 6 hours while symptoms last
  • Do not take more than 5 tablets in 24 hours.
  • Do not use for more than 5 days unless directed by a doctor 

Children under 6 years: ask a doctor

Do Not Use
  • with any other drug containing acetaminophen (prescription or non-prescription). 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
Other Information
  • store at room temperature 20°– 25°C (68°– 77°F)
  • 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

Questions Or Comments

Call 1-888-952-0050 Monday through Friday 9AM - 5PM

Principal Display Panel

Pain Relief
Pain Relief


Stop Use and Ask A Doctor If
  • Adult’s pain gets worse or lasts more than 10 days
  • Child’s pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • any new symptoms appear
If Pregnant Or Breast Feeding

ask a health professional before use.

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.

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
  • is a child with pain of arthritis

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. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours

for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if

  • adult takes more than 4,000mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours, which is the maximum daily amount
  • 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
  • do not take more than directed (see overdose warning)

Adults and children 12 years and over:

  • Take 2 tablets every 4 to 6 hours while symptoms last
  • Do not take more than 10 tablets in 24 hours, unless directed by a doctor
  • Do not use for more than 10 days unless directed by a doctor

Children 6-11 years of age:

  • Take 1 tablet every 4 to 6 hours while symptoms last
  • Do not take more than 5 tablets in 24 hours.
  • Do not use for more than 5 days unless directed by a doctor 

Children under 6 years: ask a doctor

Do Not Use (Do not use)
  • with any other drug containing acetaminophen (prescription or non-prescription). 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
Other Information (Other information)
  • store at room temperature 20°– 25°C (68°– 77°F)
  • 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

Questions Or Comments (Questions or Comments)

Call 1-888-952-0050 Monday through Friday 9AM - 5PM

Principal Display Panel

Pain Relief
Pain Relief


Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Adult’s pain gets worse or lasts more than 10 days
  • Child’s pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • any new symptoms appear
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)

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.

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
  • is a child with pain of arthritis

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)