Label: GUAIFENESIN DM- guaifenesin and dextromethorphan hydrobromide tablet
- NDC Code(s): 43063-801-60, 43063-801-90
- Packager: PD-Rx Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated September 19, 2018
If you are a consumer or patient please visit this version.
- Active Ingredient Section
Active ingredients (per tablet) Purpose
Guaifenesin 400 mg Expectorant
Dextromethorphan HBr 20 mg Cough suppressantClose
- 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)222-1222Close
- 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 04/29/2004Close
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.Close
- 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.Close
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)
- Inactive Ingredient
Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Povidone, Silicon Dioxide, Stearic AcidClose
Active Ingredient Purpose
Dextromethorphan HBr 20mg.............Cough SuppressantClose
- 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 04/29/04Close
- INGREDIENTS AND APPEARANCE
guaifenesin and dextromethorphan hydrobromide tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43063-801 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape CAPSULE Size 17mm Flavor Imprint Code PH;073 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43063-801-90 90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/14/2017 11/30/2027 2 NDC:43063-801-60 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/14/2017 11/30/2027 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 11/14/2017 11/30/2027 Labeler - PD-Rx Pharmaceuticals, Inc. (156893695) Registrant - PD-Rx Pharmaceuticals, Inc. (156893695) Establishment Name Address ID/FEI Business Operations PD-Rx Pharmaceuticals, Inc. 156893695 repack(43063-801)