Drugplain

Guaifenesin 1200 mg 1200 mg/1

Guaifenesin 1200 mg · TABLET · MARKSANS PHARMA LIMITED

No Recall History
Plain English

Guaifenesin is an over-the-counter expectorant medication taken by mouth that helps thin mucus to make coughs more productive. It is commonly used to relieve chest congestion caused by colds, flu, or other respiratory conditions.

Key Facts

Brand Name
Guaifenesin 1200 mg
Generic Name
Guaifenesin 1200 mg
NDC Code (Product)
25000-041
Manufacturer
MARKSANS PHARMA LIMITED
Strength
1200 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA217780
Drug Class
Expectorant [EPC]
Marketing Start
08/23/2023

Recall History

No Recall History

Side Effects Reported to FDA

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

dyspnoea549 reports
pneumonia517 reports
nausea469 reports
fatigue437 reports
pain420 reports
drug ineffective416 reports
diarrhoea391 reports
cough360 reports
off label use360 reports
headache356 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use(s) helps loosen phlegum (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Dosage & Administration

Directions 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: 1or 2 extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours (for 600 mg) 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 (for 1200 mg) children under 12 years of age: do not use

Warnings

Warnings Do not use For children under 12 years age Ask a doctor before use if persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied by too much phlegm (mucus) Stop use and ask doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness. If Pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children In case of overdose, get medical help or contact aPoison Control Center right away (1-800-222-1222).

Frequently Asked Questions

What is Guaifenesin 1200 mg used for?

Guaifenesin is an over-the-counter expectorant medication taken by mouth that helps thin mucus to make coughs more productive. It is commonly used to relieve chest congestion caused by colds, flu, or other respiratory conditions.

Is Guaifenesin 1200 mg a controlled substance?

Guaifenesin 1200 mg is not classified as a controlled substance by the DEA.

What is the generic name for Guaifenesin 1200 mg?

The generic name for Guaifenesin 1200 mg is Guaifenesin 1200 mg. There are no other listed brand versions of Guaifenesin 1200 mg.

What is the NDC code for Guaifenesin 1200 mg 1200 mg/1?

The NDC (National Drug Code) for Guaifenesin 1200 mg 1200 mg/1 is 25000-041, listed by MARKSANS PHARMA LIMITED.

Product NDC

25000-041

Package NDC

25000-041-12

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)