CETAFEN- acetaminophen tablet 
HART Health

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CETAFEN

Active Ingredient (in each tablet): Acetaminophen 325mg

Uses:

Temporarily relieves minor aches and pains due to:

Temporarily reduces fever

Warnings:

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

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

Ask a doctor or pharmacist before use if:

Ask a doctor before use if you have liver disease

Stop use and ask a doctor if:

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:

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

Cetafen.jpg

CETAFEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)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 
POVIDONE 
STEARIC ACID 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize12mm
FlavorImprint Code CFN
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50332-0103-450 in 1 BOX, UNIT-DOSE
12 in 1 PACKET
2NDC:50332-0103-7125 in 1 BOX, UNIT-DOSE
22 in 1 PACKET
3NDC:50332-0103-8250 in 1 BOX, UNIT-DOSE
32 in 1 PACKET
4NDC:50332-0103-1500 in 1 BOX, UNIT-DOSE
42 in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/04/1986
Labeler - HART Health (069560969)

Revised: 11/2012
Document Id: c8feb7bc-c862-489b-9d88-6cca7bc3588a
Set id: 3a18f784-429a-40c9-ac38-685c7d1f4752
Version: 1
Effective Time: 20121104
 
HART Health