Drugplain

CETAFEN 325 mg/1

ACETAMINOPHEN · TABLET · HART Health

3 Recalls on RecordCurrently in Shortage
Plain English

CETAFEN is a tablet containing acetaminophen at 325 mg/1, taken oral. Manufactured by HART Health.

Key Facts

Brand Name
CETAFEN
Generic Name
ACETAMINOPHEN
NDC Code (Product)
50332-0148
Manufacturer
HART Health
Strength
325 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
M
Marketing Start
06/04/1986

Recall History

3 Recalls on Record
Class II01/24/2022

Ultra Seal Corporation

cGMP deviations

TerminatedVoluntary: Firm initiated
Class II01/24/2022

Ultra Seal Corporation

cGMP deviations

TerminatedVoluntary: Firm initiated
Class II01/24/2022

Ultra Seal Corporation

cGMP deviations

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use22,386 reports
fatigue20,435 reports
drug ineffective18,156 reports
pain18,103 reports
nausea17,623 reports
headache16,714 reports
toxicity to various agents15,539 reports
dyspnoea14,575 reports
arthralgia14,309 reports
pyrexia14,271 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & 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 & 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

Warnings

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

Frequently Asked Questions

What is CETAFEN used for?

CETAFEN contains ACETAMINOPHEN. It is a tablet taken oral. Consult your doctor for specific uses.

Is CETAFEN a controlled substance?

CETAFEN is not classified as a controlled substance by the DEA.

What is the generic name for CETAFEN?

The generic name for CETAFEN is ACETAMINOPHEN. There are 12 other brand versions of ACETAMINOPHEN.

What is the NDC code for CETAFEN 325 mg/1?

The NDC (National Drug Code) for CETAFEN 325 mg/1 is 50332-0148, listed by HART Health.

Product NDC

50332-0148

Package NDC

50332-0148-1

Other Acetaminophen Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)