Biocotron
FDA Label NDC 45737-261

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 Biocotron (NDC 45737-261). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, otc - pregnancy or breast feeding, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients (in each 5mL)                              Purpose

Dextromethorphan HBr, 15 mg ................................. Cough Suppressant

Guaifenesin, 350 mg ................................................ Expectorant

Phenylephrine HCl, 10 mg ...................................... Nasal Decongestant

Otc - Purpose

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Indications & Usage

Uses

  • non-narcotic cough suppressant which temporarily calms cough due to minor throat and bronchial irritation as may occur with the common cold
  • calms the cough control center and relieves coughing
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive.
  • temporarily relieves nasal congestion due to the common cold
  • helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure

Warnings

Warnings:

Do no exceed recommended dosage

a persistent cough may be a sign of a serious condition. If cough persist for more than 1 week, tends to recur, or is accompanied by fever, rash or a persistent headache, constult a doctor

Do not use this product if you

are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional condition. or for two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI, ask a doctor or phamacist before taking thie product.

Ask doctor or pharmacist before use if you have

  • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
  • high blood pressure
  • heart disease
  • thyroid disease
  • diabetes
  • difficulty in urincation due to enlargment of the prostate gland

    • Stop use and ask a doctor if:

    • nervousness, dizziness, or sleeplessness occur.
    • if symptoms do not improve within 7 days or are accompanied by fever

      • Ask a doctor before use if you are taking sedatives or tranquilizers.

Otc - Keep Out Of Reach Of Children

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a doctor before use.

Dosage & Administration

Directions: Take very 4 hours, not to exceed 6 doses in 24 hours or as directed by physician

AgeDose
Adults and children 12 years of age or older1 teaspoonful (5 mL) every 4 hours
Children 6 to under 12 years of age1/2 teaspoonful (2.5 mL) every 4 hours
Children under 6 years of ageAsk a doctor

Inactive Ingredient

Inactive ingredients: citric acid, eucalyptus oil, glycerin, hydroxyethyl cellulose, methylparaben, natural and artificial flavor, polyethylene glycol, propylparaben, purified water, sodium citrate, sucralose.

Otc - Questions

Questions or comments? 1-305-403-3788

Package Label.Principal Display Panel

Biocotronped (Biocotronpedv2)

Biocotronped (Biocotronpedv2)

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