Active Ingredient (In Each 5 Ml)(One Teaspoonful)
Guaifenesin, USP 100 mg
Ritussin Expectorant
FDA Label NDC 53807-408
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 Expectorant (NDC 53807-408). 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 ingredient (in each 5 ml)(one teaspoonful), purpose, use, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Expectorant
Use
helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
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 | 2-4 teaspoons every 4 hours |
| children 6 years to under 12 years of age | 1-2 teaspoonful every 4 hours |
| children 2 years to under 6 years of age | 1/2-1 teaspoonful every 4 hours |
| children 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
caramel, citric acid, FD&C Red #40, , flavors, glucose, glycerin, high fructose corn syrup, menthol, propylene glycol, sodium saccharin, sodium benzoate, water
* Please review the disclaimer below.
