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  5. Label Information: Guaifenesin And Codeine Phosphate

FDA Label for Guaifenesin And Codeine Phosphate

View Indications, Usage & Precautions

Table of Contents

    1. USES
    2. ASK YOUR DOCTOR BEFORE USE IF
    3. WHEN USING THIS PRODUCT
    4. STOP USE AND ASK A DOCTOR IF
    5. DIRECTIONS
    6. OTHER INFORMATION
    7. INACTIVE INGREDIENTS
    8. PRINCIPAL DISPLAY PANEL-4 FL OZ (118 ML) CONTAINER LABEL
    9. PRINCIPAL DISPLAY PANEL-8 FL OZ (237 ML) CONTAINER LABEL
    10. PRINCIPAL DISPLAY PANEL-16 FL OZ (473 ML) CONTAINER LABEL

Guaifenesin And Codeine Phosphate Product Label

The following document was submitted to the FDA by the labeler of this product Quagen Pharmaceuticals Llc. 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.

Uses



  • temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
  • your cough to help you sleep
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Ask Your Doctor Before Use If



  • you have a persistent cough, this may be a sign of a serious condition
  • you have a persistent cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • you have a cough that is accompanied by excessive phlegm (mucus)
  • you have chronic pulmonary disease or shortness of breath
  • giving to a child who is taking other drugs

When Using This Product



  • giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should 
    be used to give an accurate dose of this product to children under 6 years of age.
  • may cause or aggravate constipation

Stop Use And Ask A Doctor If



  • symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms of a serious condition.

Directions



  • Do not exceed 6 doses in 24 hours.

    • Adults and children 12 years of age and over:

    2 tsp (10 mL) every 4 hours,
    or as directed by a doctor.

    Children 6 to under 12 years of age:

    1 tsp (5 mL) every 4 hours,

    or as directed by a doctor.

    Children under 6 years of age:

    Consult a doctor.


Other Information



Each tsp (5 mL) contains 3 mg sodium.

Store at controlled room temperature 15°-30°C (59°-86°F). You may report side effects by calling 1-888-344-9603 or FDA at 1-800-FDA-1088.


Inactive Ingredients



Alcohol, caramel flavor, cherry flavor, citric acid, FD&C Red #40, glycerin, peppermint flavor, purified water, sodium benzoate, sodium saccharin, sorbitol.


Principal Display Panel-4 Fl Oz (118 Ml) Container Label



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Principal Display Panel-8 Fl Oz (237 Ml) Container Label



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Principal Display Panel-16 Fl Oz (473 Ml) Container Label



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