Maxiphen DM

Dosage form: tablet
Ingredients: Guaifenesin 400mg, Phenylephrine Hydrochloride 10mg, Dextromethorphan Hydrobromide 20mg
Labeler: MCR American Pharmaceuticals, Inc.
NDC Code: 58605-423

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.

Maxiphen DM

Drug Facts

Active Ingredients
(in each immediate-release tablet)
Purpose
Dextromethorphan HBr 20 mgAntitussive
Guaifenesin 400 mgExpectorant
Phenylephrine HCl 10 mgNasal Decongestant

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies:

  • 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
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes

Warnings

  • Do not exceed recommended dosage.

  • a persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor

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 before use if you are taking sedatives or tranquilizers

Stop use and ask a doctor if
  • nervousness, dizziness or sleeplessness occur

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

Keep out of 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 hours, not to exceed 6 tablets in 24 hours, or as directed by a doctor
Children 6 to under 12 years of age:1/2 tablet by mouth every 4 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor

Inactive ingredients

Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

Question? Comments?

Call 1-352-754-8587

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

NDC 58605-0423-01

100 tablets

Maxiphen DM

Antitussive • Expectorant • Nasal Decongestant

Each immediate-release tablet contains:
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg

This bottle is not be dispensed to consumer.

Dispense in a tight light-resistant container with
a child-resistant cap.

Store at 59°-86°F (15°-30°C) [see USP
Controlled Room Temperature]

Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.

MCR American

MAXIPHEN DM 
guaifenesin, phenylephrine hydrochloride, and dextromethorphan hydrobromide tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58605-423
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin) Guaifenesin400 mg
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride10 mg
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide20 mg
Inactive Ingredients
Ingredient NameStrength
Magnesium Stearate 
Cellulose, Microcrystalline 
Sodium Starch Glycolate Type A Potato 
Product Characteristics
ColorWHITEScore2 pieces
ShapeOVAL (Capsule Shaped) Size16mm
FlavorImprint CodeMAXIPHEN;DM
Contains    
Packaging
#Item CodePackage Description
1NDC:58605-423-01100 TABLET (TABLET) in 1 BOTTLE, PLASTIC
2NDC:58605-423-0220 TABLET (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/31/2008
Labeler - MCR American Pharmaceuticals, Inc. (783383011)
Establishment
NameAddressID/FEIOperations
MCR American Pharmaceuticals, Inc.783383011MANUFACTURE
Establishment
NameAddressID/FEIOperations
TG United Inc172837085MANUFACTURE

Revised: 10/2011
 
MCR American Pharmaceuticals, 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.

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