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Delsym (Reckitt Benckiser LLC)

Available Formats

Dosage Form Package Information Links
LOZENGE 16 LOZENGE in 1 BLISTER PACK (63824-160-16) Label Information

Complete Delsym Information


    Drug Facts


    Active ingredients (in each lozenge) Purpose
    Dextromethorphan HBr 5 mg Cough suppressant
    Menthol 5 mg Oral 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 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 is accompanied by excessive 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 persistent headache. These could be signs of a serious illness

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

    Keep this and all drugs out of the 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 at room temperature 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.


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

  • PRINCIPAL DISPLAY PANEL - 16 Lozenge Carton

    NDC 63824-160-16



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

    • Quiets cough
    • Relieves sore throat
    • Soothing action



    Principal Display Panel - 16 Lozenge Carton

    dextromethorphan hydrobromide and menthol lozenge
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-160
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 5 mg
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color YELLOW Score no score
    Shape ROUND Size 27mm
    Flavor HONEY, LEMON Imprint Code D
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63824-160-16 16 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 07/01/2012
    Labeler - Reckitt Benckiser LLC (094405024)