Drugplain

SIMPEX Guaifenesin 400 mg/1

GUAIFENESIN · TABLET · Simpex Pharma Pvt. Ltd

No Recall History
Plain English

SIMPEX Guaifenesin is a tablet containing guaifenesin at 400 mg/1, taken oral. Manufactured by Simpex Pharma Pvt. Ltd.

Key Facts

Brand Name
SIMPEX Guaifenesin
Generic Name
GUAIFENESIN
NDC Code (Product)
76457-004
Manufacturer
Simpex Pharma Pvt. Ltd
Strength
400 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
M012
Drug Class
Expectorant [EPC]
Marketing Start
02/09/2018

Recall History

No Recall History

Side Effects Reported to FDA

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

dyspnoea550 reports
pneumonia517 reports
nausea468 reports
fatigue438 reports
pain420 reports
drug ineffective417 reports
diarrhoea391 reports
cough360 reports
off label use360 reports
headache356 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus

Dosage & Administration

Directions adults & children 12 years of age and older : take a tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours. children under 12 years of age : do not use.

Warnings

Warnings Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied with excessive phlegm (mucus) Stop use and ask a doctor if cough lasts more than 7 days, recurs, or is accompanied with fever, rash, or persistent headache.These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

Frequently Asked Questions

What is SIMPEX Guaifenesin used for?

SIMPEX Guaifenesin contains GUAIFENESIN. It is a tablet taken oral. Consult your doctor for specific uses.

Is SIMPEX Guaifenesin a controlled substance?

SIMPEX Guaifenesin is not classified as a controlled substance by the DEA.

What is the generic name for SIMPEX Guaifenesin?

The generic name for SIMPEX Guaifenesin is GUAIFENESIN. There are 12 other brand versions of GUAIFENESIN.

What is the NDC code for SIMPEX Guaifenesin 400 mg/1?

The NDC (National Drug Code) for SIMPEX Guaifenesin 400 mg/1 is 76457-004, listed by Simpex Pharma Pvt. Ltd.