Active Ingredient Section
Active ingredients (per tablet) Purpose
Guaifenesin 400 mg Expectorant
Dextromethorphan HBr 20 mg Cough suppressant
Guaifenesin Dm Tablet
FDA Label NDC 43063-801
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pd-rx Pharmaceuticals, Inc. for the product Guaifenesin Dm (NDC 43063-801). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient section, keep out of reach of children, indications & usage, warnings, ask doctor before use., stop use section, pregnancy or breast feeding, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately (800)222-1222
Indications & Usage
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
Warnings
WARNINGS:
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 Doctor Before Use.
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 Section
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
Pregnancy Or Breast Feeding
If pregnant or breastfeeding ask a health professional befoe use.
Questions?
Questions? Adverse drug event call : (866) 562-2756
Storage
- Other Informtion
- store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredient
Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Povidone, Silicon Dioxide, Stearic Acid
Purpose
Active Ingredient Purpose
Guaifenesin 400mg.............................Expectorant
Dextromethorphan HBr 20mg.............Cough Suppressant
Dosage & Administration
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
Package Label.Principal Display Panel
Label (43063801)
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