Label: MIELIM Y MAS- dextromethorphan liquid

  • NDC Code(s): 58593-295-04, 58593-295-06
  • Packager: Efficient Laboratories Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 14, 2024

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

  • ACTIVE INGREDIENT

    Active Ingredient: (In each teaspoonful 5 mls)                   Purpose

    Dextromethorphan HBr 15 mg (USP)................................................Cough Suppressant

  • PURPOSE

    Cough Suppressant

  • WARNINGS

    Warnings

    A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache, consult a doctor.

  • 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.

    Stop use and ask a doctor

    • if cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache.
  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of Reach of Children.

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

  • PREGNANCY OR BREAST FEEDING

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

  • DOSAGE & ADMINISTRATION

    Directions:

    Shake well immediately before use.

    Do not exceed 4 doses in any 24 hour period.

    Adults and Children 12 years and over - 10 ml (2 tsps) every 6 to 8 hours

    Children 6 to under 12 years of age - 5 ml (1 tsp) every 6 to 8 hours

    Children under 6 years of age - Consult a doctor

  • INDICATIONS & USAGE

    Temporarily relieves cough as may occur with the common cold or inhaled irritants.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Aspartame, Flavor, Honey,
    Methylparaben, Potassium Sorbate, Propylene
    Glycol, Propylparaben, Purified Water and Sodium
    Chloride.

  • QUESTIONS

    Questions or Comments?

    305.805.3456 Monday-Friday 9AM to 5PM EST

    www.efficientlabs.com


  • PRINCIPAL DISPLAY PANEL

    Mielim

  • INGREDIENTS AND APPEARANCE
    MIELIM Y MAS 
    dextromethorphan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58593-295
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    HONEY (UNII: Y9H1V576FH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58593-295-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/199705/16/2023
    2NDC:58593-295-06178 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/1997
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01202/01/1997
    Labeler - Efficient Laboratories Inc. (969044932)
    Registrant - Efficient Laboratories Inc. (969044932)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dextrum Laboratories Inc.007392322manufacture(58593-295)