Bio-z-cough Liquid
FDA Label NDC 45737-251

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-z-cough (NDC 45737-251). 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, otc - pregnancy or breast feeding, 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 tps.)                               Purpose

Dextromethorphan Hydrobromide.... 20 mg...........................Cough suppressant

Guaifenesin.... 400 mg........................................................Expectorant


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 a cold.

Warnings

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 use more than directed.

      Stop use and ask a doctor before use if:

      • 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 - Do Not Use


Do not use:

If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs of 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 MAOI; ask your doctor or pharmacist before taking this product.


Otc - Keep Out Of Reach Of Children

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

Otc - Pregnancy Or Breast Feeding

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

Dosage & Administration

Direction: do not exceed more than 6 doses in any 24 hours period.

Adults and children 12 years of age and over.
 Take 1 teaspoonful (5 mL) every 4 hours
Children under 12 years of age.
 Consult a physician

Indications & Usage


Other Information:
  • Store at room temperature 15 - 30 degrees celsius (59 - 86 degrees farenheit)
  • Tamper evident feature Do not use if seal under cap is torn, broken or missing.
  • Avoid excessive heat or humidity.



Inactive Ingredient

Inactive Ingredients:

Citric Acid, eucalyptus oil, menthol, methylparaben, propylparaben, propylene glycol, sodium citrate, polyethylene glycol, grape flavor, sucralose, and purified water.


Otc - Questions

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

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Biozcof Label (Biozcof)

Biozcof Label (Biozcof)

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