Your browser does not support JavaScript! CETAFEN EXTRA (ACETAMINOPHEN) TABLET [HART HEALTH]
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CETAFEN EXTRA (acetaminophen) tablet
[HART Health]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active Ingredient (in each caplet): Acetaminophen 500mg

Purpose: Pain Reliever / Fever Reducer

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

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

  • more than 8 caplets 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 symptms occur
  • redness or swelling is present
  • fever worsens or lasts more than 3 days
  • pain worsens or lasts 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 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:
  • take 2 caplets every 4 to 6 hours while symptoms persist
  • do not take more than 8 caplets 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: Hydroxypropyl Methylcellulose, Maltodextrin, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Sodium Starch Glycolate, Starch, Stearic Acid

CetafenExtra.jpg

CETAFEN EXTRA 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50332-0108
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
HYDROXYPROPYL METHYLCELLULOSE E5 [II] 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
PROPYLENE GLYCOL 
POVIDONE 
STEARIC ACID 
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize18mm
FlavorImprint Code CFNX
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50332-0108-320 in 1 BOX, UNIT-DOSE
12 in 1 PACKET
2NDC:50332-0108-450 in 1 BOX, UNIT-DOSE
22 in 1 PACKET
3NDC:50332-0108-7125 in 1 BOX, UNIT-DOSE
32 in 1 PACKET
4NDC:50332-0108-8250 in 1 BOX, UNIT-DOSE
42 in 1 PACKET
5NDC:50332-0108-1400 in 1 BOX, UNIT-DOSE
52 in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/05/1990
Labeler - HART Health (069560969)

Revised: 11/2012
 
HART Health

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