Active Ingredients (In Each 5 Ml)(One Teaspoonful)
Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 100 mg
Ritussin Dm
FDA Label NDC 53807-409
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rij Pharmaceutical Corporation for the product Ritussin Dm (NDC 53807-409). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each 5 ml)(one teaspoonful), purpose, use, do not use, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Cough suppressant
Expectorant
Use
temporarily relieves cough due to minor throat and bronchial irritation as may occur with cold
helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
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.
Otc - Ask Doctor
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
Otc - Stop Use
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.
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.
Directions
- do not take more than 6 doses in any 24-hour period
| age | dose |
|---|---|
| adults and children 12 years of age and over | 2 teaspoonfuls every 4 hours |
| children 6 years to under 12 years of age | 1 teaspoonful every 4 hours |
| children 2 years to under 6 years of age | 1/2 teaspoonful every 4 hours |
| under 2 years of age | ask a doctor |
Other Information
- store at room temperature 15° - 30°C (59° - 86°F)
- protect from freezing.
- protect from light.
- Each teaspoon (5 mL) contains: sodium 2 mg.
- TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING
Inactive Ingredients
citric acid, FD&C Red #40, flavors, glucose, glycerin, high fructose corn syrup, menthol, saccharin sodium, sodium benzoate, water
* Please review the disclaimer below.
