Cetafen

Cetafen
SPL v4
SPL
SPL Set ID c1162bab-377d-4e17-9417-ccd20d29148b
Route
ORAL
Published
Effective Date 2025-12-24
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

Marketing Status
OTC MONOGRAPH DRUG Active Since 1986-06-04

Description

Active Ingredient (in each tablet) : Acetaminophen 325mg


Medication Information

Warnings and Precautions

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
  • rash
  • blisters

Indications and Usage

Uses:

Temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
  • backache
  • minor arthritis pain
  • the common cold
  • toothache
  • menstrual cramps

Temporarily reduces fever

Dosage and Administration

Directions:

Do not take more than directed.

Adults and children 12 year of age and over:

  • take 2 tables every 4 to 6 hours while symptoms persist
  • do not take more than 8 tablets in 24 hours unless directed by a doctor

Children under 12 years of age: ask a doctor

Description

Active Ingredient (in each tablet) : Acetaminophen 325mg

Section 34088-5

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

Section 50565-1

Keep out of reach of children

Section 50566-9

Stop use and ask a doctor if:

  • an allergic reaction occurs, seek medical help right away
  • new symptoms occur
  • redness or swelling is present
  • fever worsens or lasts for more than 3 days
  • pain worsens or lasts for more than 10 days

These could be signs of a serious condition

Section 50568-5

Ask a doctor or pharmacist before use if:

  • you are taking the blood thinning drug warfarin
  • you do not know if other drugs you are taking contain acetaminophen

Section 50569-3

Ask a doctor before use if you have liver disease

Section 50570-1

Do not use with any other drug containing acetaminophen (prescription or non-prescription)

Section 51727-6

Inactive Ingredients: corn Starch, povidone, pregelantized starch, sodium starch glycolate, stearic acid

Section 51945-4

Section 53414-9

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

Section 55105-1

Purpose:

Pain Reliever/Fever Reducer

Section 55106-9

Active Ingredient (in each tablet): Acetaminophen 325mg

Section 60561-8

Other information:

  • tablets enclosed in a sealed packet
  • do not use if packet is torn, cut or open
  • store at 59° to 86°F (15°-30°C)
  •  avoid excessive heat and humidity

Structured Label Content

Indications and Usage (34067-9)

Uses:

Temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
  • backache
  • minor arthritis pain
  • the common cold
  • toothache
  • menstrual cramps

Temporarily reduces fever

Dosage and Administration (34068-7)

Directions:

Do not take more than directed.

Adults and children 12 year of age and over:

  • take 2 tables every 4 to 6 hours while symptoms persist
  • do not take more than 8 tablets in 24 hours unless directed by a doctor

Children under 12 years of age: ask a doctor

Warnings and Precautions (34071-1)

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
  • rash
  • blisters

Section 34088-5 (34088-5)

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

Section 50565-1 (50565-1)

Keep out of reach of children

Section 50566-9 (50566-9)

Stop use and ask a doctor if:

  • an allergic reaction occurs, seek medical help right away
  • new symptoms occur
  • redness or swelling is present
  • fever worsens or lasts for more than 3 days
  • pain worsens or lasts for more than 10 days

These could be signs of a serious condition

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if:

  • you are taking the blood thinning drug warfarin
  • you do not know if other drugs you are taking contain acetaminophen

Section 50569-3 (50569-3)

Ask a doctor before use if you have liver disease

Section 50570-1 (50570-1)

Do not use with any other drug containing acetaminophen (prescription or non-prescription)

Section 51727-6 (51727-6)

Inactive Ingredients: corn Starch, povidone, pregelantized starch, sodium starch glycolate, stearic acid

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose:

Pain Reliever/Fever Reducer

Section 55106-9 (55106-9)

Active Ingredient (in each tablet): Acetaminophen 325mg

Section 60561-8 (60561-8)

Other information:

  • tablets enclosed in a sealed packet
  • do not use if packet is torn, cut or open
  • store at 59° to 86°F (15°-30°C)
  •  avoid excessive heat and humidity

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)