Bio-g-tuss
FDA Label NDC 45737-240

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advanced Generic Corporation for the product Bio-g-tuss (NDC 45737-240). 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, purpose, uses, warnings, keep out of reach of children, directions, inactive ingredients, questions or comments, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Dextromethorphan HBr

Guaifenesin

Phenylephrine HCl

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Uses

  • helps lossen phlegm (mucus) and thin bronchial secretions to drain broncial tubes and make coughs more productive
  • temporarily relieves nasal congestion due to hay fever or other respiratory allergies (allergic rhinitis) and cough due to minor throat and bronchial irritation as may occur with the common cold

Warnings

Do not exceed recommended dosage

  • If nervousness dizziness, or sleeplessness ocurs, discontinue use and consult a doctor
  • If symptoms do not improve wihtin 7 days or are accompanied by fever, consult a doctor.

    • Do not use this product

    • for persistant or chronic cough such as occurs with asthma, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor
    • in a child who is taking a prescription Monoaminooxidase Inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, 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 who has heart disease, high blood pressure, thyroid disease, or diabetes, unless directed by a doctor.

      • Stop use and ask a doctor

      • A persistent cough may be a sign of a serious condition
      • if cough persists for more than onweek, tend to recur, or is accompanied by fever, rash or persistent headache, consult a doctor.

Keep Out Of Reach Of Children

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

Directions

 AgeDose 
 children 6 to under 12 years of age2 mL every 6-8 hours 
 chidren 2 to under 6 years of age1 mL every 6-8 hours 
 children under 2 years of ageconsult a doctor 

Inactive Ingredients

citric acid, grape flavor, glycerin, methylparaben, polyethylene glycol, propylparaben, purified water, sodium citrate, sucralose.

Questions Or Comments

1-305-403-3788

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