Drugplain

Guaifenesin Extended Release 600 mg 600 mg/1

Guaifenesin · TABLET · TIME CAP LABORATORIES, INC.

No Recall History
Plain English

Guaifenesin Extended Release 600 mg is a tablet containing guaifenesin at 600 mg/1, taken oral. Manufactured by TIME CAP LABORATORIES, INC..

Key Facts

Brand Name
Guaifenesin Extended Release 600 mg
Generic Name
Guaifenesin
NDC Code (Product)
49483-723
Manufacturer
TIME CAP LABORATORIES, INC.
Strength
600 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA217780
Drug Class
Expectorant [EPC]
Marketing Start
01/08/2024

Recall History

No Recall History

Side Effects Reported to FDA

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

dyspnoea565 reports
pneumonia534 reports
nausea480 reports
fatigue459 reports
pain435 reports
drug ineffective427 reports
diarrhoea405 reports
off label use370 reports
cough369 reports
headache365 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS & USAGE SECTION Uses • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION Directions For 600 mg • do not crush, chew, or break extended - release tablet • take with a full glass of water • this product can be administered without regard for the timing of meals • adults and children 12 years of age and over: 1 or 2 extended - release tablets every 12 hours. Do not exceed 4 extended - release tablets in 24 hours. • children under 12 years of age: do not use For 1200 mg • do not crush, chew, or break extended - release tablet • take with a full glass of water • this product can be administered without regard for the timing of meals • adults and children 12 years of age and over: 1 extended - release tablet every 12 hours. Do not exceed 2 extended - release tablets in 24 hours. • children under 12 years of age: do not use

Warnings

WARNINGS SECTION

Frequently Asked Questions

What is Guaifenesin Extended Release 600 mg used for?

Guaifenesin Extended Release 600 mg contains Guaifenesin. It is a tablet taken oral. Consult your doctor for specific uses.

Is Guaifenesin Extended Release 600 mg a controlled substance?

Guaifenesin Extended Release 600 mg is not classified as a controlled substance by the DEA.

What is the generic name for Guaifenesin Extended Release 600 mg?

The generic name for Guaifenesin Extended Release 600 mg is Guaifenesin. There are 12 other brand versions of Guaifenesin.

What is the NDC code for Guaifenesin Extended Release 600 mg 600 mg/1?

The NDC (National Drug Code) for Guaifenesin Extended Release 600 mg 600 mg/1 is 49483-723, listed by TIME CAP LABORATORIES, INC..