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CETAFEN

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg
Labeler: A-S Medication Solutions
NDC Code: 50090-2386

CETAFEN

Active Ingredient (in each tablet): Acetaminophen 325mg

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:

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

  • more than 8 tablets 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

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

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

Ask a doctor before use if you have liver disease

Stop use and ask a doctor if:

  • new symptom 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

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

Keep out of reach of children

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

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

Inactive Ingredients: Microcrystalline Cellulose, Povidone, Sodium Starch Glycolate, Starch, Stearic Acid

HOW SUPPLIED

Product: 50090-2386

NDC: 50090-2386-0 2 TABLET in a PACKET

ACETAMINOPHEN
CETAFEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-2386(NDC:50332-0103)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
POVIDONES 
STEARIC ACID 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize12mm
FlavorImprint CodeCFN
Contains    
Packaging
#Item CodePackage Description
1NDC:50090-2386-050 PACKET in 1 BOX, UNIT-DOSE
1 2 TABLET in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/04/1986
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIOperations
A-S Medication Solutions830016429RELABEL(50090-2386)

Revised: 12/2016
 
A-S Medication Solutions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.