Label: CAPRON DM- dextromethorphan hbr and pyrilamine maleate liquid

  • NDC Code(s): 29978-127-15, 29978-127-16
  • Packager: Capital Pharmaceutical, LLC
  • 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 January 10, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients      

    (in each 5 mL teaspoonful)

    Dextromethorphan HBr 7.5 mg      

  • Purpose

    Antitussive

  • Active Ingredients      

    (in each 5 mL teaspoonful)

    Pyrilamine Maleate 7.5 mg

  • Purpose

    Antihistamine

  • Uses

    temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:

    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes
    • cough due to minor throat and bronchial irritation associated with a cold
    • alleviates cough to help you sleep
    • nonnarcotic cough suppressant for the relief of cough
  • Warnings

    Do not exceed recommended dosage.

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

    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
    • for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor

    Ask a doctor before use if you have

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • difficulty in urination due to enlargement of the prostate gland

    Ask a doctor before use if you are taking

    sedatives or tranquilizers.

    When using this product

    • excitability may occur, especially in children
    • may cause marked drowsiness
    • sedatives and tranquilizers may increase drowsiness effect
    • avoid alcoholic beverages
    • use caution when driving a motor vehicle or operating machinery

    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:4 teaspoonfuls every 6-8 hours, not to exceed 16 teaspoonfuls in 24 hours, or as directed by a doctor
    Children 6 to under 12 years of age:2 teaspoonfuls every 6-8 hours, not to exceed 8 teaspoonfuls in 24 hours, or as directed by a doctor
    Children 2 to under 6 years of age
    (For Professional Use Only)     		1 teaspoonful every 6-8 hours, not to exceed 4 teaspoonfuls in 24 hours, or as directed by a doctor
    Children under 2 years of age:Consult a doctor
  • Inactive ingredients

    Citric Acid, Flavor, Magnasweet, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol, Sucralose

  • Questions or Comments?

    Call 614.638.4622      

  • PRINCIPAL DISPLAY PANEL

    labelNDC 29978-127-16

    Capron DM

    Liquid

    Candy Apple Flavor

    16 oz. (473 mL)

  • PRINCIPAL DISPLAY PANEL

    NDC 29978-127-15
    Capron DM
    Liquid
    Candy Apple Flavor
    1     5 mL

    PRINCIPAL DISPLAY PANEL NDC 29978-127-15 Capron DM Liquid Candy Apple Flavor 15 mL

  • INGREDIENTS AND APPEARANCE
    CAPRON DM 
    dextromethorphan hbr and pyrilamine maleate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29978-127
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE7.5 mg  in 5 mL
    PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE7.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorAPPLE (Candy Apple) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29978-127-156 in 1 BOX06/20/2013
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:29978-127-161 in 1 BOX06/20/2013
    2473 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/20/2013
    Labeler - Capital Pharmaceutical, LLC (831545541)
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