Guaifenesin and Dextromethorphan HBr 30 mg/1
Guaifenesin and Dextromethorphan HBr · TABLET, EXTENDED RELEASE · SUN PHARMACEUTICAL INDUSTRIES, INC.
This over-the-counter medication combines an expectorant and cough suppressant to help relieve cough and loosen mucus associated with colds or bronchitis. The extended-release tablet form allows for longer-lasting symptom relief with less frequent dosing.
Key Facts
- Brand Name
- Guaifenesin and Dextromethorphan HBr
- Generic Name
- Guaifenesin and Dextromethorphan HBr
- NDC Code (Product)
63304-106- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES, INC.
- Strength
- 30 mg/1
- Dosage Form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA214781
- Drug Class
- Expectorant [EPC]
- Marketing Start
- 07/01/2021
Recall History
Torrent Pharma Inc
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep
Dosage & Administration
Directions do not crush, chew, or break tablet take with a full glass of water this product can be administered without regard for timing of meals adults and children 12 years and older: 1 or 2 tablets every 12 hours; not more than 4 tablets in 24 hours children under 12 years of age: do not use
Warnings
Warnings Do not use for children under 12 years of age 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.
Frequently Asked Questions
What is Guaifenesin and Dextromethorphan HBr used for?
This over-the-counter medication combines an expectorant and cough suppressant to help relieve cough and loosen mucus associated with colds or bronchitis. The extended-release tablet form allows for longer-lasting symptom relief with less frequent dosing.
Is Guaifenesin and Dextromethorphan HBr a controlled substance?
Guaifenesin and Dextromethorphan HBr is not classified as a controlled substance by the DEA.
What is the generic name for Guaifenesin and Dextromethorphan HBr?
The generic name for Guaifenesin and Dextromethorphan HBr is Guaifenesin and Dextromethorphan HBr. There are 6 other brand versions of Guaifenesin and Dextromethorphan HBr.
What is the NDC code for Guaifenesin and Dextromethorphan HBr 30 mg/1?
The NDC (National Drug Code) for Guaifenesin and Dextromethorphan HBr 30 mg/1 is 63304-106, listed by SUN PHARMACEUTICAL INDUSTRIES, INC..