Label: ALTIDOME DMX- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

  • NDC Code(s): 53163-251-16
  • Packager: Alternative Pharmacal Corporation
  • 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.

Drug Label Information

Updated December 23, 2020

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients (in each 5 mL tsp.)              Purpose

    Dextromethorphan HBr ............... 30 mg ................ Cough Suppressant

    Guaifenesin .............................. 200 mg ................ Expectorant

    Phenylephrine HCl ..................... 10 mg ................... Nasal Decongestant

  • PURPOSE

    Purpose

    Cough Suppressant

    Expectorant

    Nasal Decongestant

  • WARNINGS

    Warnings

    Ask a doctor before use if you have

    • cough that occurs with too much phlegm (mucus)
    • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland

    When using this product, do not use more than directed


    Stop use and ask doctor if

    • you get nervous, dizzy or sleepless
    • symptoms do not get better within 7 days or are accompanied by fever
    • cough lasts more than 7 days, comes back or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition
  • DO NOT USE

    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 you are taking a prescription drug that contains an MAOI; ask a doctor or pharmacist before taking this product
  • PREGNANCY OR BREAST FEEDING

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

  • 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 right away.

  • INDICATIONS & USAGE

    Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
    • temporarily relieves these symptoms occuring with a cold: nasal congestion, cough due to the common cold and bronchial irritation.
  • DOSAGE & ADMINISTRATION

    Directions  Do not exceed more than 4 doses in any 24-hour period

    Adults and children 12 years of age and over            5 mL (1 tsp) every 6 hours

    Children under 12 years of age                                  consult physician

  • INACTIVE INGREDIENT

    Inactive ingredients: Citric acid, eucalyptus oil, flavors, menthol, methyl paraben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate and sucralose.

  • QUESTIONS

    Questions or comments? 1-786-507-1566

  • PRINCIPAL DISPLAY PANEL

    altidomedmxgrape

  • INGREDIENTS AND APPEARANCE
    ALTIDOME  DMX
    dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53163-251
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (Cherry Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53163-251-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/01/2013
    Labeler - Alternative Pharmacal Corporation (078528214)