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 Mckesson Corporation Dba Sky Packaging. 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.
Description
Each 5 mL (1 teaspoonful) contains: | |
Guaifenesin | 100 mg |
Dextromethorphan Hydrobromide | 10 mg |
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
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.
Principal Display Panel - 5 Ml Unit Dose Cup Label
Delivers 5 mL
NDC 63739-505-01
GUAIFENESIN SYRUP
and DEXTROMETHORPHAN
100 mg/10 mg per 5 mL
Package Not Child-Resistant
DISTRIBUTIONED BY
SKY Packaging
Memphis, TN 38141
SEE INSERT
Principal Display Panel - 10 Ml Unit Dose Cup Label
Delivers 10 mL
NDC 63739-506-01
GUAIFENESIN SYRUP
and DEXTROMETHORPHAN
200 mg/20 mg per 10 mL
Package Not Child-Resistant
DISTRIBUTIONED BY
SKY Packaging
Memphis, TN 38141
See insert
* Please review the disclaimer below.