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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 Ingredient Section

Active ingredients (per tablet) Purpose

Guaifenesin 400 mg Expectorant

Dextromethorphan HBr 20 mg Cough suppressant

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

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 DM 
guaifenesin and dextromethorphan hydrobromide tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43063-801
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
STEARIC ACID 
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize17mm
FlavorImprint CodePH;073
Contains    
Packaging
#Item CodePackage Description
1NDC:43063-801-9090 TABLET in 1 BOTTLE, PLASTIC
2NDC:43063-801-6060 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/14/201711/30/2027
Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
NameAddressID/FEIOperations
PD-Rx Pharmaceuticals, Inc.156893695repack(43063-801)

 
PD-Rx Pharmaceuticals, Inc.

← See all Guaifenesin DM brands

Medically reviewed on Sep 19, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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