Label: IOPHEN DM NR- dextromethorphan and guaifenesin liquid

  • NDC Code(s): 0603-1330-58
  • Packager: Qualitest Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 12/09

If you are a consumer or patient please visit this version.

  • Active ingredient (in each 5 mL = 1 tsp)

    Dextromethorphan HBr, USP 10 mg

    Guaifenesin, USP 100 mg

    Close
  • Purpose

    Cough suppressant

    Expectorant

    Close
  • 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 make coughs more productive
    Close
  • Warnings
  • Do not use

    • in a child under 2 years of age
    • 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.
    Close
  • Ask a doctor before use if you have

    • cough that occurs with excessive phlegm (mucus)
    • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    Close
  • STOP USE

    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.

    Close
  • PREGNANCY OR BREAST FEEDING

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

    Close
  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

    Close
  • Directions

    • take every 4 hours
    • do not take more than 6 doses in any 24-hour period

    adults and children 12 years and over

    take 10 mL (2 tsp)

    children 6 years to under 12 years

    take 5 mL (1 tsp)

    children 2 years to under 6 years

    take 2.5 mL (1/2 tsp)

    children under 2 years

    do not use

    Attention: Only use the measuring spoons or cups that are made specially for measuring drugs. Do not use common household spoons to measure medicines for children since household spoons come in different sizes and are not meant for measuring medicines.

    Close
  • Other information

    store at 15° to 30°C (59° to 86°F)

    You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

    Close
  • Inactive ingredients

    citric acid, D&C yellow #10, FD&C red #40, glycerin, propylene glycol, purified water, red raspberry flavor, saccharin sodium, sodium benzoate, sorbitol solution

    Close
  • SPL UNCLASSIFIED SECTION

    Made in the USA
    for Qualitest Pharmaceuticals
    Huntsville, AL 35811

    Rev. 10/09 R4 8066060 1330

    Close
  • PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    IOPHEN DM NR 
    dextromethorphan and guaifenesin liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0603-1330
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTROMETHORPHAN (DEXTROMETHORPHAN) DEXTROMETHORPHAN 10 mg  in 5 mL
    GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 100 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID  
    D&C YELLOW NO. 10  
    FD&C RED NO. 40  
    GLYCERIN  
    PROPYLENE GLYCOL  
    WATER  
    SACCHARIN SODIUM  
    SODIUM BENZOATE  
    SORBITOL  
    Product Characteristics
    Color ORANGE (clear) Score     
    Shape Size
    Flavor RASPBERRY (red raspberry) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0603-1330-58 473 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 05/01/1997
    Labeler - Qualitest Pharmaceuticals (011103059)
    Establishment
    Name Address ID/FEI Business Operations
    Vintage Pharmaceuticals-Huntsville 958430845 MANUFACTURE
    Close