Label: DELSYM COUGH- dextromethorphan hydrobromide 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 April 6, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each caplet)

    Dextromethorphan HBr 15 mg

  • Purpose

    Cough suppressant

  • Use

    temporarily relieves

    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the impulse to cough to help you get to sleep
  • 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

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

    Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with 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

    • dose as follows or as directed by a doctor
    • adults and children 12 years of age and over:
      take 2 caplets every 6 to 8 hours as needed, not to exceed 8 caplets in 24 hours
    • children under 12 years of age:
      do not use
  • Other information

    • store at 20-25°C (68-77°F)
  • Inactive ingredients

    FD&C yellow no. 6 aluminum lake, hypromellose, isomalt, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, titanium dioxide

  • Questions?

    1-866-682-4639

    You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    Dist. by: RB Health (US)
    Parsippany, NJ 07054-0224
    Made in India

  • PRINCIPAL DISPLAY PANEL - 20 Caplet Blister Pack Carton

    MAXIMUM STRENGTH

    NEW!

    NDC 72854-351-20

    Delsym ®

    COUGH

    Dextromethorphan HBr (Cough Suppressant)

    LASTS

    UP

    TO

    8HR

    DAY

    OR

    NIGHT

    FAST

    RELEASE

    Actual Size

    20 Caplets

    For Ages 12+

    Label

  • INGREDIENTS AND APPEARANCE
    DELSYM COUGH 
    dextromethorphan hydrobromide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72854-351
    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 YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    ISOMALT (UNII: S870P55O2W)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize13mm
    FlavorImprint Code D
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72854-351-201 in 1 CARTON07/01/2021
    120 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/01/2021
    Labeler - RB Health (US) LLC (081049410)
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