Label: COSEDAL DROPS- dextromethorphan hydrobromide and guaifenesin liquid 

  • NDC Code(s): 53145-059-02
  • Packager: Menper Distributors, Inc.
  • 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 09/13

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

  • ACTIVE INGREDIENT

    Active ingredients

    Dextromethorphan HBR

    Guaifenesin

    Close
  • PURPOSE

    Purpose

    Cough Suppressant

    Expectorant

    Close
  • INDICATIONS & USAGE

    Uses

    • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold and help loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

    Close
  • WARNINGS

    Warnings

    Do not exceed recommended dosage.

    • A persistent cough may be a sign of a serious condition. If cough persists more than one week, tends to reoccur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
    Close
  • DO NOT USE

    Do not use:

    • This product for persistent or chronic cough, such as occurs with smoking, asthma, or emphysema or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor.
    • 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
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    Close
  • PREGNANCY OR BREAST FEEDING

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

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

    Close
  • DOSAGE & ADMINISTRATION

    Directions

    Do not exceed 6 doses in 24 hours.

              age  dose

    Adults and children                                              2 teaspoonfuls (10 mL)

    12 years of age and over....................................... every 4 hours

    Children 6 to                                                       under 1 teaspoonful (5 mL)

    12 years of age..................................................... every 4 hours

    Children 2 to                                                       under 1/2 teaspoonful (2.5 mL)

    6 years of age....................................................... every 4 hours

    Children under 2 years of age.................................. consult your doctor

    Close
  • OTHER SAFETY INFORMATION

    Other information

    Store this product between 15°-30°C (59°-86°F)

    Close
  • INACTIVE INGREDIENT

    Inactive ingredients Citric acid, D&C red #33, glycerin, methylparaben, natural raspberry flavor, propylene glycol, propylparaben , purified water, sucrose

    Close
  • QUESTIONS

    Questions? call 1-800-560-5223 M-F 9 AM to 4 PM Eastern.

    Close
  • INGREDIENTS AND APPEARANCE
    COSEDAL DROPS 
    dextromethorphan hbr, guaifenesin liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53145-059
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg  in 5 mL
    GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 100 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID ACETATE  
    D&C RED NO. 33  
    GLYCERIN  
    METHYLPARABEN  
    PROPYLENE GLYCOL  
    PROPYLPARABEN  
    RASPBERRY  
    SUCROSE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53145-059-02 1 in 1 CARTON
    1 60 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 02/21/2012
    Labeler - Menper Distributors, Inc. (101947166)
    Close