Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID c4f82ed8-b82c-47bb-9ab9-108a13d29cf7
Route
ORAL
Published
Effective Date 2023-11-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

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

Warnings and Precautions

Liver warning:This product contains acetaminophen.  The manxium daily dose of this product is 10 tablets (3,250 mg) in 24 hours fro 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 acetaminphen 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 or 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 allergic to acetaminophen.

Ask a doctor before use if user has:liver disease

Ask a doctor or pharmacist before use if:

  • the user is taking the blood thinnig drug warfarin.
  • is a child with pain of arthritis

Stop use and ask a doctor if:

  • Adults pain gets worse or lasts for more than 10 days.  
  • Childs pain gets worse or last fr more than 5 days.
  • Fever gets worse or lasts for more than 3 days.  
  • New symptoms occur.  
  • Redness or swelling is present.  

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

Overdose warning:taking more than the recommended dose (overdose) may cause liver damage.  In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.  Quick medical action is critical for adults as well as for children, even if you do not notice any signs or symptoms.

Purpose

Pain reliever / Fever reducer

Dosage and Administration

Adults and children 12 years of age and older: 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 take 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 more than 5 days unless directed by a doctor.

Children under 6 years of age: Ask a doctor

Description

Acetaminophen 325mg

Uses
  • Temporary relief of minor aches and pains associated with: headache, muscular aches, backache, minor pain from arthritis, the common cold, toothache, premenstrual and menstrual cramps
  • Temporarily reduces fever
Section 51727-6

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

Section 51945-4
Active Ingredient

Acetaminophen 325mg

Keep Out of Reach of Children

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


Structured Label Content

Uses
  • Temporary relief of minor aches and pains associated with: headache, muscular aches, backache, minor pain from arthritis, the common cold, toothache, premenstrual and menstrual cramps
  • Temporarily reduces fever
Dosage and Administration (34068-7)

Adults and children 12 years of age and older: 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 take 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 more than 5 days unless directed by a doctor.

Children under 6 years of age: Ask a doctor

Warnings and Precautions (34071-1)

Liver warning:This product contains acetaminophen.  The manxium daily dose of this product is 10 tablets (3,250 mg) in 24 hours fro 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 acetaminphen 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 or 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 allergic to acetaminophen.

Ask a doctor before use if user has:liver disease

Ask a doctor or pharmacist before use if:

  • the user is taking the blood thinnig drug warfarin.
  • is a child with pain of arthritis

Stop use and ask a doctor if:

  • Adults pain gets worse or lasts for more than 10 days.  
  • Childs pain gets worse or last fr more than 5 days.
  • Fever gets worse or lasts for more than 3 days.  
  • New symptoms occur.  
  • Redness or swelling is present.  

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

Overdose warning:taking more than the recommended dose (overdose) may cause liver damage.  In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.  Quick medical action 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)
Purpose

Pain reliever / Fever reducer

Active Ingredient

Acetaminophen 325mg

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

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


Advanced Ingredient Data


Raw Label Data

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