Defensol-ito

Defensol-ito
SPL v4
SPL
SPL Set ID 2a3f498d-445f-410b-818f-9f119bd6c492
Route
ORAL
Published
Effective Date 2017-10-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (80 mg) Phenylephrine (2.5 mg)
Inactive Ingredients
Aspartame Carboxymethylcellulose Sodium Lactose Magnesium Stearate Polyvinyl Acetate Phthalate Silicon Dioxide Starch, Corn Sugarcane Talc

Identifiers & Packaging

Pill Appearance
Shape: round Color: pink Size: 10 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-02-21

Description

Active ingredients (in each tablet) Acetaminophen 80 mg Phenylephrine Hydrochloride 2.5 mg


Medication Information

Warnings and Precautions

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.

Indications and Usage

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
Dosage and Administration

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

Description

Active ingredients (in each tablet) Acetaminophen 80 mg Phenylephrine Hydrochloride 2.5 mg

Section 34088-5

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

Section 50565-1

Keep out of reach of children.

Section 50566-9

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
Section 50570-1

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
Section 51727-6

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

Section 51945-4

Section 53413-1

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

Section 53414-9

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

Section 55105-1

Purpose

Pain reliever/ Fever Reducer

Nasal Decongestant

Section 55106-9

Active ingredients (in each tablet)

Acetaminophen 80 mg

Phenylephrine Hydrochloride 2.5 mg


Structured Label Content

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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.

Section 34088-5 (34088-5)

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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
Section 50570-1 (50570-1)

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
Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Pain reliever/ Fever Reducer

Nasal Decongestant

Section 55106-9 (55106-9)

Active ingredients (in each tablet)

Acetaminophen 80 mg

Phenylephrine Hydrochloride 2.5 mg


Advanced Ingredient Data


Raw Label Data

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