Label: RUGBY CHEST CONGESTION RELIEF DM- dextromethorphan hydrobromide / guaifenesin 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 August 15, 2023

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  • ACTIVE INGREDIENT

    Active ingredient - (per tablet)

    Dextromethorphan Hydrobromide   20mg

    Guaifenesin  400mg

  • PURPOSE

    Purpose

    Cough Suppressant

    Expectorant

  • Uses

    ■ Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold
    ■ Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
    ■ Helps make coughs more productive.

  • Warnings

    Do not use  ■ if you are now taking a prescription monoamine oxidase (inhiMor~MAIO) (Certain drugs for depression, psychiatric or emotional conditioners or Parkinson's disease)or for 2 weeks after stopping MAIO drug, If you do not know if your prescription drug contains an MAIO, ask your doctor or pharmacist before using this product.

  • ASK DOCTOR

    Ask doctor before use if you have
    ■ persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysma
    ■ cough is accompanied by excessive phlegm (mucus)

  • STOP USE

    Stop use and ask doctor if

    ■ symptoms are accompanied by fever, rash or persistent headache
    ■ cough persists for more than 1 week or tends to recur.
    A persistent cough may be a sign of a serious condition.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In  case of overdose, get medical help or contact a Poison Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions
    ■ Adults and children 12 years of age and over:take 1 tablet every 4 hours as needed.
    ■ Children 6 to 10 under 12 years of age: take 1/2 tablet every 4 hours as needed.
    ■ Children under 6 years of age: consult a doctor.   
    Do not exceed 6 doses in a 24 hour period or as directed by a doctor

  • Other Information

    Store at 15°-30°C (59°-86°F)

  • INACTIVE INGREDIENT

    Inactive Ingredients magnesium stearate, microcrystalline cellulose. May also contain (colloidal) silicon dioxide, (co) povidone, dicalcium phosphate, maltodextrin, sodium starch glycolate, stearic acid.

  • HOW SUPPLIED

    NDC: 71335-2216-1: 30 Tablets in a BOTTLE

    NDC: 71335-2216-2: 20 Tablets in a BOTTLE

    NDC: 71335-2216-3: 18 Tablets in a BOTTLE

    NDC: 71335-2216-4: 60 Tablets in a BOTTLE

  • PRINCIPAL DISPLAY PANEL

    Guaifenesin/DM 400/20 mg Tablet

    Label
  • INGREDIENTS AND APPEARANCE
    RUGBY CHEST CONGESTION RELIEF  DM
    dextromethorphan hydrobromide / guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-2216(NDC:0536-1312)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize17mm
    FlavorImprint Code PH073
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71335-2216-130 in 1 BOTTLE; Type 0: Not a Combination Product08/15/2023
    2NDC:71335-2216-220 in 1 BOTTLE; Type 0: Not a Combination Product08/15/2023
    3NDC:71335-2216-318 in 1 BOTTLE; Type 0: Not a Combination Product08/15/2023
    4NDC:71335-2216-460 in 1 BOTTLE; Type 0: Not a Combination Product08/15/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/01/2020
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(71335-2216) , RELABEL(71335-2216)
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