Label: CAROLINA CRUD CRUSHER- dextromethorphan hbr, guaifenesin syrup

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 30, 2023

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  • Active ingredients (in each teaspoonful (5 mL))

    Dextromethorphan HBr, USP 10 mg

    Guaifenesin, USP 100 mg

  • Purposes

    Cough suppressant

    Expectorant

  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to:
    • drain bronchial tubes
    • make coughs more productive
    • rid bronchial passageways of bothersome mucus
    • temporarily relieve cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • 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 for more than 1 week, comes back, or occurs with a 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

    • take every 4 hours
    • do not take more than 6 doses in 24 hours

    adults and children 12 years and over2 teaspoonfuls (10 mL)
    children 6 to under 12 years1 teaspoonful (5 mL)
    children 2 to under 6 years 1/2 teaspoonful (2-1/2 mL)
    children under 2 yearsask a doctor

  • Other information

    • store at 20º C to 25º C (68º F 77º F)
    • do not refrigerate
    • to report serious side effects due to the use of this product call (515) 276-1586
  • Inactive ingredients

    citric acid (anhydrous), FD&C red no. 40, flavor, glycerin, high fructose corn syrup, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose

  • PRINCIPAL DISPLAY PANEL

    Principal Display PanelCarolina Crud Crusher

    Expectorant DM Tasty Cough Syrup

    • Loosens & Relieves Chest Congestion
    • Cough Suppressant
  • INGREDIENTS AND APPEARANCE
    CAROLINA CRUD CRUSHER 
    dextromethorphan hbr, guaifenesin syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11383-311
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MENTHOL (UNII: L7T10EIP3A)  
    Product Characteristics
    Colorred (Red to Orange-red) Score    
    ShapeSize
    FlavorPINEAPPLEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11383-311-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/01/2022
    Labeler - Weeks & Leo Co., Inc. (005290028)
    Registrant - Weeks & Leo Co., Inc. (005290028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Weeks & Leo Co., Inc.005290028manufacture(11383-311)
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