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GUAIFENESIN DM


Non-Narcotic, Alcohol Free Expectorant/Cough Suppressant


DESCRIPTION

Each 5 mL (1 teaspoonful) contains:
Guaifenesin100 mg
Dextromethorphan Hydrobromide10 mg

Inactive Ingredients: Citric acid, FD&C Red No. 40, flavoring, glycerin, menthol, purified water, sodium benzoate, sodium citrate, sodium saccharin, and sucrose. 

Sodium Content: 4 mg/5 mL


USES

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

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.


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

Stop use and ask a doctor 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.
  • you are hypersensitive to any of the ingredients.

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


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


Professional Note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).


DIRECTIONS: Follow dosage below or use as directed by a physician.

adults and children 12 years and over 10 mL (2 teaspoonfuls) every 4 hours
children 6 years to under 12 years 5 mL (1 teaspoonful) every 4 hours
children 2 years to under 6 years 2.5 mL (1/2 teaspoonful) every 4 hours
children under 2 yearsask a doctor
  • do not take more than 6 doses in any 24-hour period.

HOW SUPPLIED: Guaifenesin Syrup and Dextromethorphan is a red, cherry flavored syrup supplied in the following oral dosage forms:

NDC 63739-505-01  5 mL unit dose cup

NDC 63739-505-10  Case contains 100 unit dose cups of 5 mL (63739-505-01) packaged in 10 trays of 10 unit dose cups each.

NDC 63739-506-01  10 mL unit dose cup

NDC 63739-506-10  Case contains 100 unit dose cups of 10 mL (63739-506-01) packaged in 10 trays of 10 unit dose cups each.


STORAGE: Keep tightly closed.  Store at controlled room temperature, 20°-25°C (68°-77°F) [See USP].  Protect from light.