Drugplain

GUAIFENESIN DM 10 mg/5mL

GUAIFENESIN and DEXTROMETHORPHAN · SYRUP · Cardinal Health 107, LLC

1 Recall on Record
Plain English

GUAIFENESIN DM is a syrup containing guaifenesin and dextromethorphan at 10 mg/5mL, taken oral. Manufactured by Cardinal Health 107, LLC.

Key Facts

Brand Name
GUAIFENESIN DM
Generic Name
GUAIFENESIN and DEXTROMETHORPHAN
NDC Code (Product)
55154-5785
Manufacturer
Cardinal Health 107, LLC
Strength
10 mg/5mL
Dosage Form
SYRUP
Route
ORAL
Marketing Status
Application #
M012
Drug Class
Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]; Sigma-1 Agonist [EPC]
Marketing Start
07/01/1992

Recall History

1 Recall on Record
Class II01/08/2016

Perrigo Company PLC

Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective135 reports
diarrhoea86 reports
dizziness69 reports
dyspnoea66 reports
headache57 reports
nausea54 reports
fatigue50 reports
pneumonia48 reports
cough45 reports
expired product administered43 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 temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep

Dosage & Administration

Directions do not crush, chew, or break tablet take with a full glass of water this product can be administered without regards for timing of meals adults and children 12 years of age and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours children under 12 years of age: do not use

Warnings

Warnings Do not use for children under12 years of age if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. 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) When using this product, do not use more than directed. 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 GUAIFENESIN DM used for?

GUAIFENESIN DM contains GUAIFENESIN and DEXTROMETHORPHAN. It is a syrup taken oral. Consult your doctor for specific uses.

Is GUAIFENESIN DM a controlled substance?

GUAIFENESIN DM is not classified as a controlled substance by the DEA.

What is the generic name for GUAIFENESIN DM?

The generic name for GUAIFENESIN DM is GUAIFENESIN and DEXTROMETHORPHAN. There are 11 other brand versions of GUAIFENESIN and DEXTROMETHORPHAN.

What is the NDC code for GUAIFENESIN DM 10 mg/5mL?

The NDC (National Drug Code) for GUAIFENESIN DM 10 mg/5mL is 55154-5785, listed by Cardinal Health 107, LLC.