CETAFEN EXTRA- 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 EXTRA

Active Ingredient (in each caplet): Acetaminophen 500mg

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 a Poison Control Center right away. 1-800-222-1222.

Directions:

Do not take more than directed

Adults and children 12 years of age and over:

Children under 12 years of age: ask a doctor

Other information:

Inactive Ingredients: corn starch, hypromellose, polyethylene glycol, povidone, pregelantized starch, sodium starch glycolate, stearic acid, titanium dioxide

CetafenExtra.jpg

CETAFEN EXTRA 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0149
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize17mm
FlavorImprint Code AZ012
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50332-0149-320 in 1 BOX, UNIT-DOSE01/05/1990
12 in 1 PACKET; Type 0: Not a Combination Product
2NDC:50332-0149-450 in 1 BOX, UNIT-DOSE01/05/1990
22 in 1 PACKET; Type 0: Not a Combination Product
3NDC:50332-0149-7125 in 1 BOX, UNIT-DOSE01/05/1990
32 in 1 PACKET; Type 0: Not a Combination Product
4NDC:50332-0149-8250 in 1 BOX, UNIT-DOSE01/05/1990
42 in 1 PACKET; Type 0: Not a Combination Product
5NDC:50332-0149-1400 in 1 BOX, UNIT-DOSE01/05/1990
52 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/05/1990
Labeler - HART Health (069560969)

Revised: 8/2023
Document Id: df467d13-9a76-4a87-b33a-1d4c9427ce7b
Set id: 38db0b09-37f8-4fed-903e-81e89486b39b
Version: 1
Effective Time: 20230815
 
HART Health