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 Pharmaceutical Associates, 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.
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
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
Directions
- shake well before using
- do not take more than 6 doses in any 24-hour period
age dose adults and children 12 years and over 10 mL (2 teaspoonsful) every 4 hours children 6 to under 12 years of age 5 mL (1 teaspoonful) every 4 hours children 2 to under 6 years of age 2.5 mL (1/2 teaspoonful) every 4 hours children under 2 years consult a doctor
Other Information
- each teaspoonful contains: sodium 4 mg
- store at 20° - 25°C (68° - 77°F)
- alcohol/sugar free
- red, cherry flavored solution supplied in the following oral dosage forms: NDC 0121-0809-04 (4 fl oz bottle), NDC 0121-0809-08 (8 fl oz bottle), NDC 0121-4809-05 (unit dose cups of 5 mL, packaged in trays of 10), and NDC 0121-4809-10 (unit dose cups of 10 mL, packaged in trays of 10).
Inactive Ingredients
Acesulfame K, citric acid, FD&C Red No. 40, flavoring, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol and sucralose.
Questions Or Comments?
Call 1-800-845-8210. You may also report serious side effects to this phone number.
Principal Display Panel - 118 Ml Label
NDC 0121-0809-04
Quality®
Value
Maximum Strength
Guaifenesin DM
Cough & Chest
Congestion
DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)
ALCOHOL / SUGAR FREE
Relieves Cough /
Maximum Strength
Mucus Relief
4 fl oz (118 mL)
Principal Display Panel - 5 Ml Lid
Delivers 5 mL
NDC 0121-4809-05
MAXIMUM STRENGTH
GUAIFENESIN DM
Guaifenesin (Expectorant)
Dextromethorphan HBr (Cough Suppressant)
200 mg/10 mg per 5 mL
Alcohol Free / Sugar Free
FOR INSTITUTIONAL USE ONLY
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
SEE INSERT
* Please review the disclaimer below.