GADAVYT COUGH DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]

GADAVYT COUGH DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC]
PDF | XML

NDC 53113-557-04
Set ID 1906ab0e-42dc-4619-87a3-d7a30f432a95
Category HUMAN OTC DRUG LABEL
Packager Gadal Laboratories Inc
Generic Name
Product Class
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Active Ingredient (in each 5 mL tsp.)              Purpose

    Dextromethorphan HBr                                      Cough Suppressant

    Guaifenesin 100mg                                          Expectorant

  • PURPOSE

    USES

    • temporarily quiets cough associated with the common cold or inhaled irritants
    • Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • WARNINGS

    Warnings
    Ask a doctor before use if

    • you have cough that lasts or a chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema.
    • cough occurs with too much phlegm (mucus)
  • DO NOT USE

    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 you are taking a prescription drug that contains an MAOI, ask a doctor or pharmacist before taking this product.

    Stop use and ask a doctor if

    • cough lasts for more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children. In case of
    overdose, get medical help or contact a Poison Control Center
    right away.

  • PREGNANCY OR BREAST FEEDING

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

  • DOSAGE & ADMINISTRATION

    Directions

    do not take more than 6 doses in any 24 hour period

    adults and children 12 years and over
    2 TSP every 4 hours or as directed by doctor
    children under 12 years
    do not use
  • INDICATIONS & USAGE

    Other information
    store at room temperature  15 - 30 degrees C (59 - 86 degrees F)
    TAMPER-EVIDENT: Do not use if seal under cap is torn,
    broken or missing.

  • INACTIVE INGREDIENT

    Inactive Ingredients
    Citric acid, methylparaben, propylparaben,glycerin, sucralose,
    sodium citrate, FD and C Red No. 40, menthol, natrosol, cherry flavor,
    purified water

  • QUESTIONS

    GADAL Laboratories, Inc.

    Miami, Fl 33186

    www.gadallaboratories.com

  • PRINCIPAL DISPLAY PANEL

    coughdmlabel

  • INGREDIENTS AND APPEARANCE
    GADAVYT COUGH  DM
    dextromethorphan hydrobromide, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-557
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (Cherry Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53113-557-04118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/01/2012
    Labeler - Gadal Laboratories Inc (841305639)

Related Drugs