Biocotron
FDA Label NDC 45737-209

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 45737-209). 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 - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, indications & usage, 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 5 mL tsp.)              Purpose

Dextromethorphan Hydrobromide 10 mg.................. Cough Suppressant

Guaifenesin 100 mg .............................................. Expectorant

Otc - Purpose

Uses

  • temporarily relieves cough due to minor throat and bronchial irritations as may occur with a cold
    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

    • When using this product, do not exceed recommended dosage

    Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

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 your doctor or pharmacist before taking this product.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Dosage & Administration

Directions Do not take more than 6 doses in any 24-hour period, unless directed by a physician

adults and children 12 years and over, 2 teaspoonfuls every 4 hours

children 6 years to under 12 years, 1 teaspoonful every 4 hours

children under 6 years, ask a doctor

Indications & Usage

Other information store at controlled room temperature
20-25 C (68-77 F); excursion permitted to 15-30 C (59-86 F). Tamper
evident by imprinted heat seal under cap. Do not use if there is
evidence of tampering.
Warning: Phenylketonuric: Contains 11.25 mg of phenylalanine per 5 ml (one teaspoonful) dose.

Inactive Ingredient

Inactive ingredients Aspartame, citric acid, flavor, glycerine,
hydroxyethylcellulose, methylparaben, propylene glycol, purified
water and sodium citrate.

Otc - Questions

Questions or comments? 1-305-403-3788
Manufactured For: Advanced Generic Corporation, Miami, FL 33166.
www.advancedgeneric.com

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