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 Type HUMAN OTC DRUG Item Code (Source) NDC:50332-0103
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Color white Score no score
Shape ROUND Size 12mm
Flavor Imprint Code CFN
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50332-0103-4 50 in 1 BOX, UNIT-DOSE
1 2 in 1 PACKET
2 NDC:50332-0103-7 125 in 1 BOX, UNIT-DOSE
2 2 in 1 PACKET
3 NDC:50332-0103-8 250 in 1 BOX, UNIT-DOSE
3 2 in 1 PACKET
4 NDC:50332-0103-1 500 in 1 BOX, UNIT-DOSE
4 2 in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 06/04/1986
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