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

Purpose:

Pain Reliever/Fever Reducer

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:

Allergy alert:  Acetaminophen may cause severe skin reactions. Symptoms may include:

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: ask a doctor

Other information:

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

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CETAFEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0103
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
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-DOSE06/04/1986
12 in 1 PACKET; Type 0: Not a Combination Product
2NDC:50332-0103-7125 in 1 BOX, UNIT-DOSE06/04/1986
22 in 1 PACKET; Type 0: Not a Combination Product
3NDC:50332-0103-8250 in 1 BOX, UNIT-DOSE06/04/1986
32 in 1 PACKET; Type 0: Not a Combination Product
4NDC:50332-0103-1500 in 1 BOX, UNIT-DOSE06/04/1986
42 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/04/1986
Labeler - HART Health (069560969)

Revised: 8/2023
Document Id: 59312948-c3b0-4ea5-b84c-57fa694d4464
Set id: 3a18f784-429a-40c9-ac38-685c7d1f4752
Version: 8
Effective Time: 20230811
 
HART Health