FDA Label for Guaifenesin Dm
View Indications, Usage & Precautions
Guaifenesin Dm Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health 107, 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.
Otc - Purpose
Non-Narcotic, Alcohol Free
Expectorant/Cough Suppressant
Description
Each 5 mL (1 teaspoonful) contains: | |
Guaifenesin | 100 mg |
Dextromethorphan Hydrobromide | 10 mg |
Inactive Ingredient
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
Otc - Do Not Use
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
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.
Other
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).
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
Dosage & Administration
DIRECTIONS: Follow dosage below or use as directed by a physician.
• do not take more than 6 doses in any 24-hour period.
| age | dose |
|---|---|
adults and children | 10 mL (2 teaspoonfuls) |
children 6 years to | 5 mL (1 teaspoonful) |
children 2 years to | 2.5 mL (1/2 teaspoonful) |
children under 2 years | ask a doctor |
Storage And Handling
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
L54347410120
R11/16
Principal Display Panel
Guaifenesin Syrup and Dextromethorphan
200 mg/ 20 mg per 10 mL
5 Cups
* Please review the disclaimer below.