Drugplain

Guaifenesin 200mg 200 mg/1

Guaifenesin · TABLET · HEALTHLIFE OF USA LLC

10 Recalls on Record
Plain English

Guaifenesin 200mg is a tablet containing guaifenesin at 200 mg/1, taken oral. Manufactured by HEALTHLIFE OF USA LLC.

Key Facts

Brand Name
Guaifenesin 200mg
Generic Name
Guaifenesin
NDC Code (Product)
69517-148
Manufacturer
HEALTHLIFE OF USA LLC
Strength
200 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
M012
Drug Class
Expectorant [EPC]
Marketing Start
08/22/2025

Recall History

10 Recalls on Record
Class II01/24/2022

Ultra Seal Corporation

cGMP deviations

TerminatedVoluntary: Firm initiated
Class II01/24/2022

Ultra Seal Corporation

cGMP deviations

TerminatedVoluntary: Firm initiated
Class II01/24/2022

Ultra Seal Corporation

cGMP deviations

TerminatedVoluntary: Firm initiated
Class II01/24/2022

Ultra Seal Corporation

cGMP deviations

TerminatedVoluntary: Firm initiated
Class II01/24/2022

Ultra Seal Corporation

cGMP deviations

TerminatedVoluntary: Firm initiated
Class II01/24/2022

Ultra Seal Corporation

cGMP deviations

TerminatedVoluntary: Firm initiated
Class II01/24/2022

Ultra Seal Corporation

cGMP deviations

TerminatedVoluntary: Firm initiated
Class II01/24/2022

Ultra Seal Corporation

cGMP deviations

TerminatedVoluntary: Firm initiated
Class II01/24/2022

Ultra Seal Corporation

cGMP deviations

TerminatedVoluntary: Firm initiated
Class II01/24/2022

Ultra Seal Corporation

cGMP deviations

TerminatedVoluntary: Firm initiated

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 passageway of bothersome mucus and make coughs more productive

Dosage & Administration

Directions: Do not take more than 6 doses in any 24-hour period. This product is not intended for use in children under 12 years of age Adults & children 12 years and over: 1 to 2 tablets every 4 hours Children under 12 years: 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 by too much phlegm (mucus) Stop use and ask a doctor if cough last more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. There could be signs of a serious illness. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. 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.

Frequently Asked Questions

What is Guaifenesin 200mg used for?

Guaifenesin 200mg contains Guaifenesin. It is a tablet taken oral. Consult your doctor for specific uses.

Is Guaifenesin 200mg a controlled substance?

Guaifenesin 200mg is not classified as a controlled substance by the DEA.

What is the generic name for Guaifenesin 200mg?

The generic name for Guaifenesin 200mg is Guaifenesin. There are 12 other brand versions of Guaifenesin.

What is the NDC code for Guaifenesin 200mg 200 mg/1?

The NDC (National Drug Code) for Guaifenesin 200mg 200 mg/1 is 69517-148, listed by HEALTHLIFE OF USA LLC.