Label: MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM- dextromethorphan hydrobromide and guaifenesin capsule, gelatin coated

  • NDC Code(s): 68210-4107-1
  • Packager: Spirit Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 8, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each softgel)Purposes
    Dextromethorphan HBr, USP 10 mgCough suppressant
    Guaifenesin, USP 200 mgExpectorant
  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • 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

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

    Stop use and ask a doctor if cough lasts 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 right away.

  • Directions

    • do not take more than 12 softgels in any 24-hour period
    • this adult product is not intended for use in children under 12 years of age
    agedose
    adults and children 12 years and over2 softgels every 4 hours
    children under 12 yearsdo not use
  • Other information

    • store at 20-25°C (68-77°F).
    • avoid excessive heat above 40°C (104°F).
  • Inactive ingredients

    FD&C Red-40, gelatin, glycerin, polyethylene glycol 400, povidone K30, propylene glycol, purified water, special sorbitol, titanium dioxide

  • Questions or comments?

    1-888-333-9792

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY:
    SPIRIT PHARMACEUTICALS LLC

    RONKONKOMA, NY 11779

  • PRINCIPAL DISPLAY PANEL

    VALUMEDS TM

    Compare to the active ingredients in Robitussin® Maximum

    Strength Cough+Chest Congestion  DM*

    Maximum Strength

    Cough + Chest Congestion DM

    DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT
    GUAIFENESIN/ EXPECTORANT

    MAXIMUM STRENGTH

    Relieves

    • cough
    •  mucus

    10 SOFTGELS
    Liquid Filled capsules

    image description

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM 
    dextromethorphan hydrobromide and guaifenesin capsule, gelatin coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4107
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorred (Light red) Scoreno score
    ShapeOVAL (Oblong) Size20mm
    FlavorImprint Code 242;905
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-4107-11 in 1 CARTON07/30/2020
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/30/2020
    Labeler - Spirit Pharmaceuticals LLC (179621011)
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