Label: CAPRON DMT- dextromethorphan hbr and pyrilamine maleate tablet

  • 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 March 12, 2020

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  • Directions

    Do not exceed recommended dosage.

    Adults and children 12 years of age and over:1 tablet every 6-8 hours.
    Children under 12 years of age:Consult a physician.
  • Other information

    Store at 15 o-30 oC (59 o-86 oF).

    Capron DMT is a white, round tablet, debossed with "DMT" on one side and blank of the other side.

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

  • Active ingredients (in each tablet)

    Dextromethorphan HBr 30 mg

    Pyrilamine Maleate 30 mg

    Purposes

    Antitussive

    Antihistamine

  • 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
    • runny nose
    • itchy watery eyes
    • itching of the nose and throat
    • relief of cough
  • Do not exceed recommended dosage.

    • May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.
  • 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 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
    • thyroid disease
    • diabetes
    • trouble urinating due to enlargement of the prostate gland
  • Stop use and ask doctor if

    • cough 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.

    Inactive ingredients

    Croscarmellose Sodium, Magnesium Stearate,

    Microcrystalline Cellulose, Silicon Dioxide.

    Questions? Comments?

    Serious side effects may be reported to this number.

    Call 1 (614) 638-4622.

  • PRINCIPAL DISPLAY PANEL

    Manufactured for:

    Capital Pharma

    Powell, OH 43065

    Rev. 09/16

    PDP

    drug facts

  • INGREDIENTS AND APPEARANCE
    CAPRON DMT 
    dextromethorphan hbr and pyrilamine maleate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29978-128
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg
    PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE30 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize7mm
    FlavorImprint Code DMT
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29978-128-10100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/26/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/26/2017
    Labeler - Capital Pharma (831545541)
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