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  5. Label Information: Bio-z-cough

FDA Label for Bio-z-cough

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. WARNINGS
    4. OTC - DO NOT USE
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. OTC - PREGNANCY OR BREAST FEEDING
    7. DOSAGE & ADMINISTRATION
    8. INDICATIONS & USAGE
    9. INACTIVE INGREDIENT
    10. OTC - QUESTIONS
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bio-z-cough Product Label

The following document was submitted to the FDA by the labeler of this product Advanced Generic Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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

Package Label.Principal Display Panel



biozcof label - biozcof

biozcof label - biozcof


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