FDA Label for Chest Congestion Relief DM
View Indications, Usage & Precautions
Chest Congestion Relief DM Product Label
The following document was submitted to the FDA by the labeler of this product Rugby Laboratories. 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 - Active Ingredient
Active ingredient
Dextromethorphan HBr, 10 mg
Guaifenesin 100 mg
Otc - Purpose
Purpose
Cough suppressant
Expectorant
Indications & Usage
Uses
- temporarily relieves cough due to minor thoat and bronchial irritation
- helps loosen phlegm (mucus)
- helps thin bronchial secretions to make coughs more productive
Warnings
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, 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.
Do not use ifyou have ever had an allergic reaction to any of the ingredients in this product.
Ask a doctor before use if you have
- a cough with too much phlegm (mucus)
- a 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 headache that lasts. These could be signs of a serious condition.
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 (1-800-222-1222) right away
Dosage & Administration
Directions
- take every 4 hours as needed, or as directed by a doctor
- do not take moer than 6 doses in 24 hours
- do not exceed recommended dose
| Adults and children 12 years and over | 2 teasponsfuls (10 mL) |
| Children under 12 years | do not use |
Inactive Ingredient
Inactive ingredients: Cherry flavor, citric acid, FD&C Red #40, menthol, methylparaben, propylene glycol, propylparaben, water, sodium citrate, sucralose, sucrose.
Otc - Questions
1-800-645-2158
Package Label.Principal Display Panel
* Please review the disclaimer below.