CETAFEN

Manufacturer
HART Health
Effective date
2025-12-24
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:28:29

Label at a glance#

ProductCETAFEN
Active ingredientACETAMINOPHEN
Label structure15 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each tablet): Acetaminophen 325mg

OTC - PURPOSE SECTION

Purpose:

Pain Reliever/Fever Reducer

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver disease

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

OVERDOSAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cetafen.jpgCetafen.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313782acetaminophen 325 MG Oral TabletPSN4
1358837Cetafen 325 MG Oral TabletPSN4
1358837acetaminophen 325 MG Oral Tablet [Cetafen]SBD4
313782acetaminophen 325 MG Oral TabletSCD4
313782APAP 325 MG Oral TabletSY4
1358837APAP 325 MG Oral Tablet [Cetafen]SY4
1358837Cetafen 325 MG Oral TabletSY4

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50332-014850332-0148-4, 50332-0148-7, 50332-0148-8, 50332-0148-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CETAFENACETAMINOPHENHART Healthc1162bab-377d-4e17-9417-ccd20d29148b2025-12-24WarningsExact identifier
ndc (package): 50332-0148-7
ndc (package): 50332-0148-4
ndc (package): 50332-0148-8
ndc (package): 50332-0148-1
ndc (product): 50332-0148
ndc11 (package): 50332014804
ndc11 (package): 50332014808
ndc11 (package): 50332014801
ndc11 (package): 50332014807
spl id: 43f28d4d-7e38-4681-87aa-edb1268a1add
spl set id: c1162bab-377d-4e17-9417-ccd20d29148b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.