Label: CAPMIST DM- dextromethorphan hydrobromide, guaifenesin and pseudoephedrine hydrochloride tablet

  • NDC Code(s): 29978-601-30, 29978-601-90
  • Packager: Capital Pharmaceutical, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 26, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    (in each tablet)

    Dextromethorphan HBr 15mg

  • Purpose

    Cough Suppressant

  • Active ingredients

    (in each tablet)

    Guaifenesin 400mg

  • Purpose

    Expectorant

  • Active ingredients

    (in each tablet)

    Pseudoephedrine HCl 60mg

  • Purpose

    Nasal Decongestant

  • Uses

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

    • cough due to minor throat and bronchial irritation 
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
    • nasal congestion
    • reduces swelling of nasal passages
  • Warnings

    Do not exceed recommended dosage.

    Do not use this product

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

    Stop use and ask a doctor if:

    • nervousness, dizziness, or sleeplessness occur
    • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
    • new symptoms occur

    If pregnant or breast feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    Do not exceed recommended dosage.
    Adults and children 12 years of age and over:1 tablet every 4 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctor.
    Children 6 to under 12 years of age:1/2 tablet every 4 hours, not to exceed 2 tablets in 24 hours, or as directed by a doctor.
    Children 2 to under 6 years of age:Consult a doctor.
  • Other information

    Store at 15°-30°C (59°-86°F).

    Capmist DM is a light green, oblong, capsule shaped, scored tablet, debossed “CAP” bisect “DM” on one side and blank on the other.

    Contains color additives including FD&C Yellow No. 5 (tartrazine).

    Supplied in a tight, light-resistant container with a child-resistant cap.

  • Inactive ingredients

    FD&C Blue #1, FD&C Yellow #5, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate.

  • PRINCIPAL DISPLAY PANEL

    NDC 29978-601-90
    CAPMIST DM Tablets
    Cough Suppressant ● Expectorant
    Nasal Decongestant

    90 tablets

    PRINCIPAL DISPLAY PANEL
NDC 29978-601-90
CAPMIST DM Tablets
Cough Suppressant ● Expectorant
Nasal Decongestant
90 tablets

  • PRINCIPAL DISPLAY PANEL

    NDC 29978-601-30
    CAPMIST DM Tablets
    Cough Suppressant ● Expectorant
    Nasal Decongestant

    3
    0 samples

    PRINCIPAL DISPLAY PANEL
NDC 29978-601-30
CAPMIST DM Tablets
Cough Suppressant ● Expectorant
Nasal Decongestant
30 samples

  • INGREDIENTS AND APPEARANCE
    CAPMIST DM 
    dextromethorphan hydrobromide, guaifenesin and pseudoephedrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29978-601
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    Colorgreen (light green) Score2 pieces
    ShapeCAPSULE (oblong) Size19mm
    FlavorImprint Code CAP;DM
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29978-601-302 in 1 BOX06/20/2013
    115 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:29978-601-9090 in 1 BOTTLE; Type 0: Not a Combination Product06/20/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/20/2013
    Labeler - Capital Pharmaceutical, LLC (831545541)