Defensol Adult Syrup Liquid
FDA Label NDC 53145-039

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Menper Distributors, Inc. for the product Defensol Adult Syrup (NDC 53145-039). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each 10ml tsp), purposes, uses, warnings, do not use:, if you are pregnant or breast-feeding,, directions:do not exceed 6 doses in 24 hours., other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each 10Ml Tsp)

Dextromethorphan HBr 20 mg……………………Cough suppressant

Guaifenesin 200 mg………………………………Expectorant

Purposes

Cough Suppressant

Expectorant

Uses

Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold and helps loosen phlegm (mucus) and thin brochial secretions to make cougs  more productive. 

Warnings

Do not exceed recommended dosage.

A persistent cough may be a sign of a serious condition. If cough persists more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

Do Not Use:

  • This product for persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis or emphysema or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

If You Are Pregnant Or Breast-Feeding,

ask a health professional before use.

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

Directions:Do Not Exceed 6 Doses In 24 Hours.

 age dose
 Adults and children12 years of age and over 2 teaspoonfuls (10 mL) every 4 hours
 Children under 12 years of age Do not use

Other Information

  • Store this product between 15°-30°C (59°-86°F)

Inactive Ingredients

citric acid, D&C red #33, glycerin, methylparaben, propylene glycol, propylparaben ,raspberry flavor, sucrose,water,

Question?

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