Cetafen Extra
38db0b09-37f8-4fed-903e-81e89486b39b
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:07:53.422445 · Updated: 2026-03-14T23:11:51.346073