ExeFen DMX

Dosage form: tablet
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 20mg, GUAIFENESIN 400mg, PSEUDOEPHEDRINE HYDROCHLORIDE 60mg
Labeler: Larken Laboratories, Inc.
NDC Code: 68047-155

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.

ExeFen DMX

Drug Facts

Active Ingredients

(in each immediate-release tablet)

Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Pseudoephedrine HCl 60 mg

Purpose

Dextromethorphan HBr                Antitussive
Guaifenesin                                     Expectorant
Pseudoephedrine HCl                   Nasal Decongestant

Uses

temporarily relieves

  • cough due to minor throat or bronchial irritation associated with a cold
  • cough impulses without narcotics
  • helps loosen phlegm and thin bronchial secretions to make coughs more productive
  • nasal congestion
  • sinus congestion and pressure due to a cold or hay fever

Warnings
  • Do not exceed recommended dosage.
  • a persistent cough may be a sign of a serious condition

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 you have
  • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or if cough is accompanied by excessive phlegm
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use
  • If you are taking sedatives or tranquilizers

Stop use and ask a doctor if
  • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache
  • nervousness, dizziness or sleeplessness occur

If pregnant or breast-feeding
  • ask a health professional before use.

Keep out of the reach of children.
  • In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and over:1 tablet by mouth every 4 to 6 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctor
Children 6 to under 12 years of age:Consult a doctor

Inactive Ingredients

Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

Questions?  Comments?

Call 1-888-527-5522

Principal Display Panel

Figure 1: Container Label

Figure 2: Label Text

Figure 3: Label Text

EXEFEN DMX 
dextromethorphan hydrobromide, guaifenesin and pseudoephedrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68047-155
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorWHITEScore2 pieces
ShapeOVAL (Modified) Size16mm
FlavorImprint CodeLL155
Contains    
Packaging
#Item CodePackage Description
1NDC:68047-155-01100 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/28/2011
Labeler - Larken Laboratories, Inc. (791043719)
Registrant - Larken Laboratories, Inc. (791043719)
Establishment
NameAddressID/FEIOperations
TG United, Inc.172837085MANUFACTURE

Revised: 01/2011
 
Larken Laboratories, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web4)