Drugplain

Guaifenesin and Dextromethorphan HBr 60 mg/1

Guaifenesin and Dextromethorphan HBr · TABLET, EXTENDED RELEASE · Aurohealth LLC

1 Recall on Record
Plain English

Guaifenesin and Dextromethorphan HBr is a tablet, extended release containing guaifenesin and dextromethorphan hbr at 60 mg/1, taken oral. Manufactured by Aurohealth LLC.

Key Facts

Brand Name
Guaifenesin and Dextromethorphan HBr
Generic Name
Guaifenesin and Dextromethorphan HBr
NDC Code (Product)
58602-825
Manufacturer
Aurohealth LLC
Strength
60 mg/1
Dosage Form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
ANDA206941
Drug Class
Expectorant [EPC]
Marketing Start
03/17/2017

Recall History

1 Recall on Record
Class II05/21/2019

Torrent Pharma Inc

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dehydration3 reports
renal failure acute3 reports
anaemia2 reports
cardio-respiratory arrest2 reports
chronic obstructive pulmonary disease2 reports
colitis2 reports
completed suicide2 reports
convulsion2 reports
deep vein thrombosis2 reports
dyspnoea2 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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?

Guaifenesin and Dextromethorphan HBr contains Guaifenesin and Dextromethorphan HBr. It is a tablet, extended release taken oral. Consult your doctor for specific uses.

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 60 mg/1?

The NDC (National Drug Code) for Guaifenesin and Dextromethorphan HBr 60 mg/1 is 58602-825, listed by Aurohealth LLC.