Biocotron-d
FDA Label NDC 45737-208

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-d (NDC 45737-208). 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, warnings, otc - do not use, otc - keep out of reach of children, dosage & administration, inactive ingredient, otc - questions, 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, 10 mg ................................. Cough Suppressant

Guaifenesin, 200 mg ................................................ Expectorant

Phenylephrine HCl, 5 mg ...................................... Nasal Decongestant



Otc - Purpose

Uses

Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes. Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold. Temporarily relieves nasal congestion due to the common cold.

Warnings

Warnings:

Ask a doctor before use if you have:

Heart disease, high blood pressure, thyroid disease, diabetes, trouble urinating due to an enlarged prostate gland, cough that last or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.

Ask doctor or pharmacist before use if you are taking any other nasal decongestant or stimulant.

When using this product do not use more than directed.


Otc - Do Not Use

Do not use.

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 you are taking a prescription drug that contains an MAOI, ask a doctor or pharmacist before taking this product.

Stop use and ask a doctor before use if:

  • you get nervous, dizzy or sleepless; symptoms do not get better within 7 or are accompanied by fever
  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

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.

Dosage & Administration

Directions: Do not take more than 3 doses in any 24-hour period.

Age
Dose
Adults and children 12 years of age and over
2 teaspoons every 4 hours
Children 6 to under 12 years of age
1 teaspoon every 4 hours
Children 2 to under 6 years of age1/2 teaspoon every 4 hours
Children under 2 years of ageAsk a doctor

Inactive Ingredient

Inactive ingredients: Carboxymethyl cellulose sodium, Cellulose, Citric Acid, Flavor, Propylene Glycol, Sodium Benzoate, Sodium Saccharin, Water

Otc - Questions

Questions or comments? 1-305-403-3788

Indications & Usage

Other information:Store at room temperature 15-30 degrees C (59-86 degrees F)

Tamper evident:Do not use if seal under cap (or cello-band over cap) is torn, broken or missing.

Each teaspoonful (5mL) contains:Sodium 6 mg

Package Label.Principal Display Panel

Biocotron (Biocotron)

Biocotron (Biocotron)

Otc - Pregnancy Or Breast Feeding

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

* Please review the disclaimer below.