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  5. Label Information: Counteract Cough

FDA Label for Counteract Cough

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - ASK DOCTOR
    6. OTC - STOP USE
    7. OTC - PREGNANCY OR BREAST FEEDING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DOSAGE & ADMINISTRATION
    10. STORAGE AND HANDLING
    11. INACTIVE INGREDIENT
    12. OTC - QUESTIONS
    13. GENERAL PRECAUTIONS

Counteract Cough Product Label

The following document was submitted to the FDA by the labeler of this product Melaleuca, Inc.. 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 tsp)
Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 100 mg


Otc - Purpose



Purpose
Dextromethorphan HBr, USP 10 mg..........Cough Suppressant
Guaifenesin, USP 100 mg............................Expectorant


Indications & Usage



Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Warnings



Warnings
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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Otc - Ask Doctor



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

Otc - Stop Use



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


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. In case of overdose, get medical help or contact a Poison Control Center right away.


Dosage & Administration



Directions

  • do not take more than 6 doses in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age
    age
    		dose
    adults and children
    12 years and over
    		2 tsp every
    4 hours
    children under 12 years
    		do not use

Storage And Handling



Other information

  • store at 20°-25°C (68°-77°F)

Inactive Ingredient



Inactive ingredients  anhydrous citric acid, FD and C red no. 40, flavors, glycerin, high fructose corn syrup, propylene glycol, purified water, saccharin sodium, sodium benzoate


Otc - Questions



Questions or comments?
1-800-282-3000


General Precautions



DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSING


* Please review the disclaimer below.