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Defensolito

Medically reviewed on October 24, 2017

Dosage form: tablet, chewable
Ingredients: ACETAMINOPHEN 80mg, PHENYLEPHRINE HYDROCHLORIDE 2.5mg
Labeler: Menper Distributors, Inc.
NDC Code: 53145-006

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.

Active ingredients (in each tablet)
Acetaminophen 80 mg

Phenylephrine Hydrochloride 2.5 mg

Purpose

Pain reliever/ Fever Reducer

Nasal Decongestant

Uses

Temporarily relieves

  • nasal decongestion due to a common cold, hay fever or other upper respiratory allergies, nasal stuffiness, sinus congestion and pressure
  • minor aches and pains associated with the common cold, sore throat, headache, tootheache and flu

Warnings

Do not exceed recommended dosage. Do not give to children under 6 years of age.

Liver toxicity may occur if

  • recommended dosage is exceeded
  • used with other products containing acetaminophen
  • used with moderate amounts of alcohol

Drug Interaction Precaution: Do not use in a child who is taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, or Parkinson's Disease), or for two weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Do not give this product to a child unless directed by a doctor:

  • with any other products containing acetaminophen (prescription or non-prescription)
  • if you are not sure whether a drug contains acetaminophen
  • if your child is allergic to acetaminophen or any other ingredients in the product
  • for more than 5 days for pain
  • for more than 3 days for fever
  • who has heart disease, high blood pressure, thyroid disease, or diabetes
  • who is taking blood thinning drug warfarin
  • if your child has liver disease

Stop use and ask doctor promptly if

  • pain persists and gets worse, if new symptoms occur or if redness or swelling is present because these could be signs of a serious condition
  • symptoms do not improve or are accompanied by a fever
  • if sore throat is severe, persists for more than 2 days, is accompanied or followed by a fever, headache, rash, nausea or vomiting
  • nervousness, dizziness, or sleeplessness occur

If pregnant or breast feeding, ask a health care professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms

Directions

  • Do not take more than 6 doses (12 chewable tablets) in a 24 hour period
 Children 6 to under 12 years of age  take 2 chewable tablets every 4 hours
 Children under 6 years of age consult a doctor

Inactive Ingredients Aspartame, Carboxymethylcellulose Sodium, FD&C #40 aluminum lake, Flavor, Lactose, Magnesium Stearate, Polyvinyl Pirrolidone, Silicon Dioxide, Starch, Sugar and Talc.

Questions? Call 1-800-560-5223 weekdays 9 AM-4 PM EST

DEFENSOLITO 
acetaminophen, phenylephrine hydrochloride tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-006
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN80 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME 
CARBOXYMETHYLCELLULOSE SODIUM 
LACTOSE 
MAGNESIUM STEARATE 
POLYVINYL ACETATE PHTHALATE 
SILICON DIOXIDE 
STARCH, CORN 
SUGARCANE 
TALC 
Product Characteristics
ColorpinkScore2 pieces
ShapeROUNDSize10mm
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:53145-006-0250 PACKET in 1 CARTON
12 TABLET, CHEWABLE in 1 PACKET
2NDC:53145-006-301 BOTTLE in 1 BOX
230 TABLET, CHEWABLE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/21/2012
Labeler - Menper Distributors, Inc. (101947166)

 
Menper Distributors, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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