GUAIFENESIN DM
OTC - PURPOSE SECTION
Non-Narcotic, Alcohol Free Expectorant/Cough Suppressant
DESCRIPTION
| Each 5 mL (1 teaspoonful) contains: | |
| Guaifenesin | 100 mg |
| Dextromethorphan Hydrobromide | 10 mg |
INACTIVE INGREDIENT SECTION
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
OTC - DO NOT USE SECTION
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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
SPL UNCLASSIFIED SECTION
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).
DOSAGE & ADMINISTRATION SECTION
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 years | ask a doctor |
- •do not take more than 6 doses in any 24-hour period.
SPL UNCLASSIFIED SECTION
HOW SUPPLIED: Guaifenesin Syrup and Dextromethorphan is a red, cherry flavored syrup supplied in the following oral dosage forms:
Overbagged with 5 x 10 mL unit dose cups per bag, NDC 55154-5783-5
STORAGE AND HANDLING SECTION
STORAGE: Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F) [See USP]. Protect from light.
MANUFACTURED BY
Pharmaceutical Associates, Inc.Greenville, SC 29605 www.paipharma.com
Distributed By:
Cardinal Health
Dublin, OH 43017
L54347410124
R11/16