Drugplain

mucus extended release 1200 mg/1

guaifenesin · TABLET, MULTILAYER, EXTENDED RELEASE · CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

No Recall History
Plain English

Guaifenesin Extended Release is an over-the-counter expectorant tablet that helps thin mucus to make coughs more productive when you have chest congestion. It comes in a 1200 mg extended-release formulation taken by mouth.

Key Facts

Brand Name
mucus extended release
Generic Name
guaifenesin
NDC Code (Product)
51316-400
Manufacturer
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Strength
1200 mg/1
Dosage Form
TABLET, MULTILAYER, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
ANDA078912
Drug Class
Expectorant [EPC]
Marketing Start
06/17/2025

Recall History

No Recall History

Side Effects Reported to FDA

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

dyspnoea549 reports
pneumonia516 reports
nausea468 reports
fatigue437 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 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 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 Do not use • for children under 12 years of age Ask a doctor before use if you have • 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 a 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 breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Frequently Asked Questions

What is mucus extended release used for?

Guaifenesin Extended Release is an over-the-counter expectorant tablet that helps thin mucus to make coughs more productive when you have chest congestion. It comes in a 1200 mg extended-release formulation taken by mouth.

Is mucus extended release a controlled substance?

mucus extended release is not classified as a controlled substance by the DEA.

What is the generic name for mucus extended release?

The generic name for mucus extended release is guaifenesin. There are 12 other brand versions of guaifenesin.

What is the NDC code for mucus extended release 1200 mg/1?

The NDC (National Drug Code) for mucus extended release 1200 mg/1 is 51316-400, listed by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED.

Product NDC

51316-400

Package NDC

51316-400-55

Other Guaifenesin Brands

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

Data from openFDA · Public domain (CC0 1.0)