ACTIDOM DMX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACTIPHARMA, INC]

ACTIDOM DMX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACTIPHARMA, INC]
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NDC 63102-110-16
Set ID 0166322e-7dbb-4658-a5c5-1d0525bb7655
Category HUMAN OTC DRUG LABEL
Packager Actipharma, Inc
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • Drug Facts

  • Active Ingredients (in each 5 mL tsp)

    Dextromethorphan HBr, 30 mg
    Guaifenesin, 200 mg
    Phenylephrine HCl, 10 mg

  • Purpose

    Cough Suppressant

    Expectorant

    Nasal Decongestant

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental 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 occurring with a cold: nasal congestion, cough due to minor throat and bronchial irritation.

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

    When using this product • do not exceed recommended dosage

    Stop use and ask a doctor if • you get nervous, dizzy or sleepless • symptoms do not get better within 7 days or are accompanied by fever • coughs lasts more than 7 days, comes back, or is accompanied by fever, rash, or a persistent headache. These could be signs of a serious condition.

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

  • DOSAGE & ADMINISTRATION

    Directions • do not take more than 4 doses in any 24-hour period.

     Adults and Children 12 years of age and over          5 mL (1tsp), every 6 hours
     Children under 12 years of age                                            ask a doctor

  • INACTIVE INGREDIENT

    Inactive ingredients: Citric acid, D&C Red 40, FD&C Blue#1, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate and sucralose.

  • OTHER SAFETY INFORMATION

    Other information • Store at room temperature 15° - 30ºC (59º - 86ºF) • protect from freezing • protect from light • Avoid excessive heat or humidity. TAMPER EVIDENT: Do not use if inner seal is torn, broken or missing.

  • SPL UNCLASSIFIED SECTION

    Manufactured in the USA for ActiPharma, Inc. Dorado, PR 00646. Tel: (787)608-0882

    * Dometuss-DMX® is a registered trademark of Domel Laboratories. This product is not manufactured, distributed or marketed by Domel Laboratories.

    Contains the same active ingredients as Dometuss®-DMX*

    COUGH SUPPRESSANT

    EXPECTORANT

    NASAL DECONGESTANT

    SUGAR FREE

    ALCOHOL FREE

    Grape Flavor

  • Packaging

    Actidom DMX

  • INGREDIENTS AND APPEARANCE
    ACTIDOM DMX 
    dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63102-110
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Colorpurple (Clear) Score    
    ShapeSize
    FlavorgrapeImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63102-110-16474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/13/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/13/2015
    Labeler - Actipharma, Inc (079340948)