Guaifenesin DM by PD-Rx Pharmaceuticals, Inc.
Dosage form: tablet
Ingredients: GUAIFENESIN 400mg, DEXTROMETHORPHAN HYDROBROMIDE 20mg
Labeler: PD-Rx Pharmaceuticals, Inc.
NDC Code: 43063-801
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Active ingredients (per tablet) Purpose
Guaifenesin 400 mg Expectorant
Dextromethorphan HBr 20 mg Cough suppressant
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately (800)222-1222
Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold
Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
Helps make coughs more productive.
These highlights do not include all the information needed to use Guaifenesin DM, See full prescribing information for Guaifenesin DM Initial U.S. Approval 04/29/2004
Do not use, 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
- Persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis or emphysema
- Cough accompanied by excessive phegm (mucus)
Stop use and ask a doctor if
- Symptons are accompanied by fever, rash or persistent headache
- cough persists for more than 1 week or tends to recur
- A persistent cough may be a sign of a serious sondition
If pregnant or breastfeeding ask a health professional befoe use.
Questions? Adverse drug event call : (866) 562-2756
- Other Informtion
- store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Povidone, Silicon Dioxide, Stearic Acid
Active Ingredient Purpose
Dextromethorphan HBr 20mg.............Cough Suppressant
Directions: Adults and children 12 years of age and older, take 1 tablet every 4 hours as needed with a full glass of water while symptoms persist.
Do not exceed 6 doses in 24 hours.
Children 6 to 12 years of age take 1/2 tablet every 4 hours as needed with a full glass of water.
Children under 6 years of age consult a doctor.
These highlights do not include all the information needed to use Guaifenesin DM
See full prescribing information for Guaifenesin DM
Initial U.S. Approval 04/29/04
guaifenesin and dextromethorphan hydrobromide tablet
|Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)|
|Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)|
|PD-Rx Pharmaceuticals, Inc.||156893695||repack(43063-801)|
Medically reviewed on Sep 19, 2018