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
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 February 18, 2020

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 Product02/01/1997
    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 finalpart34102/01/1997
    Labeler - Efficient Laboratories Inc. (969044932)
    Registrant - Efficient Laboratories Inc. (969044932)