Label: DELSYM COUGH PLUS SOOTHING ACTION- dextromethorphan hydrobromide and menthol lozenge

  • 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 May 1, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each lozenge)Purposes
    Dextromethorphan HBr 5 mgCough suppressant
    Menthol 5 mgOral pain reliever
  • Uses

    temporarily relieves

    • sore throat
    • sore mouth
    • minor mouth irritation
    • cough due to minor throat and bronchial irritation as may occur with the common cold
  • Warnings

    Sore throat warning

    • If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly.

    Do not use in a child under 6 years of age.

    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

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

    Stop use and ask a doctor or dentist if

    • sore mouth symptoms do not improve in 7 days
    • irritation, pain, or redness persists or worsens
    • swelling develops
    • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. 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

    • adults and children 12 years and older: take 2 lozenges (one immediately after the other) and allow each lozenge to dissolve slowly in the mouth; may be repeated every 4 hours, not to exceed 12 lozenges in any 24-hour period, or as directed by a doctor
    • children 6 to under 12 years of age: take 1 lozenge and allow to dissolve slowly in the mouth; may be repeated every 4 hours, not to exceed 6 lozenges in 24 hours, or as directed by a doctor
    • children under 6 years of age: do not use
  • Other information

    • tamper evident: product is sealed in blister package for your protection. Do not use if carton is damaged or if printed seal on blister is broken or missing.
    • store between 20-25°C (68-77°F)
  • Inactive ingredients

    D&C Yellow #10, FD&C Yellow #6, flavors, liquid glucose, propylene glycol, sucralose, sucrose, water

  • Questions?

    Call 1-888-963-3382

    You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    Dist. by: Reckitt Benckiser
    Parsippany, NJ 07054-0224
    Made in England

  • PRINCIPAL DISPLAY PANEL - 16 Lozenge Carton

    NDC 63824-164-16

    Delsym®

    COUGH +™
    SOOTHING
    ACTION

    LOZENGES

    Dextromethorphan HBr 5 mg (Cough Suppressant)
    Menthol 5 mg (Oral Pain Reliever)

    ✓
    Quiets Cough
    ✓
    Relieves Sore Throat
    ✓
    Soothing Action

    16 LOZENGES

    Honey
    Lemon

    Principal Display Panel - 16 Lozenge Carton
  • INGREDIENTS AND APPEARANCE
    DELSYM   COUGH PLUS SOOTHING ACTION
    dextromethorphan hydrobromide and menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-164
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide5 mg
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol5 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    propylene glycol (UNII: 6DC9Q167V3)  
    sucralose (UNII: 96K6UQ3ZD4)  
    sucrose (UNII: C151H8M554)  
    water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeROUNDSize20mm
    FlavorHONEY, LEMONImprint Code S
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-164-162 in 1 CARTON
    18 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34104/12/2013
    Labeler - Reckitt Benckiser LLC (094405024)
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