ROBAFEN COUGH NON-DROWSY FORMULA (DEXTROMETHORPHAN HBR) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES]

  • Home
  • ROBAFEN COUGH NON-DROWSY FORMULA (DEXTROMETHORPHAN HBR) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES]

ROBAFEN COUGH NON-DROWSY FORMULA (DEXTROMETHORPHAN HBR) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES]
PDF | XML
NDC 0536-1068-34
Set ID 206fff2b-1b9d-4b7f-bcef-b055825d4fe7
Category HUMAN OTC DRUG LABEL
Packager Rugby Laboratories
Generic Name
Product Class
Product Number
Application Number PART341
View All Sections
  • 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 (1-800-222-1222) 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • avoid excessive heat above 40ºC (104ºF)
    • protect from light
    • see bottle for lot number and expiration date
  • Inactive ingredients

    edible white ink, FD&C blue #1, FD&C red#40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol

  • Questions or comments?

    1-800-645-2158

  • Principal display panel

    Rugby®

    NDC 0536-1068-34

    Compare to the active ingredient in Robitussin® Long-Acting CoughGels®*

    Non-Drowsy Formula
    ROBAFEN® COUGH
    LIQUIDGELS

    Dextromethorphan HBr, USP 15 mg
    Cough Suppressant

    8-Hour Cough Relief

    Easy-to-Swallow
    Liquid-Filled
    Capsules

    20
    Liquidgels
    (Liquid-Filled
    Capsules) 

    Distributed by:
    Rugby Laboratories
    17177 N Laurel Park Drive
    Suite 233
    Livonia, MI 48152
    www.rugbylaboratories.com
    R-17
    Rev. 05/19
    Re-Order No. 370416

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

    *This product is not manufactured or distributed by Wyeth LLC, owner of the registered trademark Robitussin® Long-Acting CoughGels®.

    50844   REV0319C66109

    Product of China

    Packaged and Quality Assured in the USA

    Rugby 44-661

    Rugby 44-661

  • INGREDIENTS AND APPEARANCE
    ROBAFEN COUGH  NON-DROWSY FORMULA
    dextromethorphan hbr capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1068
    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)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Colorred (clear) Scoreno score
    ShapeOVALSize10mm
    FlavorImprint Code 661
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1068-341 in 1 PACKAGE03/01/2015
    120 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/01/2015
    Labeler - Rugby Laboratories (079246066)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(0536-1068)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(0536-1068)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(0536-1068)
View All Sections

Related Drugs

Search DailyMed Drugs