Cetafen Extra

Cetafen Extra
SPL v3
SPL
SPL Set ID 38db0b09-37f8-4fed-903e-81e89486b39b
Route
ORAL
Published
Effective Date 2023-08-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Hypromelloses Polyethylene Glycol, Unspecified Starch, Corn Stearic Acid Titanium Dioxide Povidone, Unspecified

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1990-01-05

Description

Active Ingredient (in each caplet): Acetaminophen 500mg


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 years of age and over:

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

Children under 12 years of age: ask a doctor

Description

Active Ingredient (in each caplet): Acetaminophen 500mg

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 a 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 symptms occur
  • redness or swelling is present
  • fever worsens or lasts more than 3 days
  • pain worsens or lasts 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, hypromellose, polyethylene glycol, povidone, pregelantized starch, sodium starch glycolate, stearic acid, titanium dioxide

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 caplet): Acetaminophen 500mg

Section 60561-8

Other information:

  • caplets 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 years of age and over:

  • take 2 caplets every 4 to 6 hours while symptoms persist
  • do not take more than 8 caplets 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 a 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 symptms occur
  • redness or swelling is present
  • fever worsens or lasts more than 3 days
  • pain worsens or lasts 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, hypromellose, polyethylene glycol, povidone, pregelantized starch, sodium starch glycolate, stearic acid, titanium dioxide

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 caplet): Acetaminophen 500mg

Section 60561-8 (60561-8)

Other information:

  • caplets 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)