Label: DEXTROMETHORPHAN HBR capsule, liquid filled

  • 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 October 29, 2022

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  • Active ingredient (in each liquid-filled capsule)

    Dextromethorphan HBr, USP 15 mg

  • Purpose

    Cough suppressant

  • Use

    temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

  • 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

    • a cough that occurs with too much phlegm (mucus)
    • a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema

    Stop use and ask a doctor if

    cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

    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 take more than 8 capsules in any 24-hour period
    • this adult product is not intended for use in children under 12 years of age
    • adults and children 12 years and over: take 2 capsules every 6 to 8 hours, as needed
    • children under 12 years: do not use
  • Other information

    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • protect from light, heat and moisture
    • see bottle for lot number and expiration date
  • Inactive ingredients

    FD&C blue #1, FD&C red #40, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, propyl gallate, propylene glycol, purified water, sorbitol sorbitan solution, white ink

  • Questions or comments?

    1-800-645-2158

  • Principal display panel

    Rugby®

    NDC 0536-1323-34

    Compare to the
    active ingredient in
    Robitussin® CoughGels®*

    Dextromethorphan HBr
    USP
    15 mg

    Cough Suppressant

    Up to 8 Hours
    For Ages 12 and Over
    Non-Drowsy

    20 Liquidgels
    (Liquid Filled Capsules)

    Actual Size

    Distributed by:
    RUGBY® LABORATORIES
    17177 N Laurel Park Drive
    Suite 233
    Livonia, MI 48152
    www.rugbylaboratories.com

    Rev. 10/20

    PARENTS:
    Learn about teen medicine abuse
    www.StopMedicineAbuse.org

    *This product is
    not manufactured
    or distributed by
    PF Consumer Healthcare 1 LLC,
    owner of the
    registered
    trademark Robitussin®
    CoughGels®.

    50844 ORG012073209

    Product of Dubai
    Packaged and
    Quality Assured
    in the USA

    KEEP OUTER
    PACKAGE FOR
    COMPLETE
    PRODUCT
    INFORMATION

    TAMPER EVIDENT: DO NOT USE IF
    IMPRINTED SAFETY SEAL UNDER
    CAP IS BROKEN OR MISSING

    Rev. 10/20   R-17   Re-Order No. 371074

    Rugby 44-732

    Rugby 44-732

  • INGREDIENTS AND APPEARANCE
    DEXTROMETHORPHAN HBR 
    dextromethorphan hbr capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1323
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Colorred (clear) Scoreno score
    ShapeOVALSize14mm
    FlavorImprint Code 732
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1323-341 in 1 PACKAGE10/30/2020
    120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/30/2020
    Labeler - Rugby Laboratories (079246066)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(0536-1323)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(0536-1323)
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