Cetafen Extra

Cetafen Extra
SPL v1
SPL
SPL Set ID 207cf327-b35c-405c-979e-af25183e6ae5
Route
ORAL
Published
Effective Date 2012-11-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Hydroxypropyl Methylcellulose E5 [ii] Maltodextrin Cellulose, Microcrystalline Propylene Glycol Povidone Stearic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 1990-01-05
Description

Active Ingredient (in each caplet): Acetaminophen 500mg

Medication Information

Warnings and Precautions

Warning: Liiver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 8 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
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: do not use; this will provide more than the recommended dose (overdose) for children under 12 years of age and may cause liver damage.

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

  • 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: Hydroxypropyl Methylcellulose, Maltodextrin, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Sodium Starch Glycolate, Starch, 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 caplet): Acetaminophen 500mg

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: do not use; this will provide more than the recommended dose (overdose) for children under 12 years of age and may cause liver damage.

Warnings and Precautions (34071-1)

Warning: Liiver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 8 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
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

  • 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: Hydroxypropyl Methylcellulose, Maltodextrin, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Sodium Starch Glycolate, Starch, 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 caplet): Acetaminophen 500mg

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:33.119950 · Updated: 2026-03-14T22:53:19.872567