Label: ROMPE PECHITO DM FOR KIDS- dextromethorphan hbr, guaifenesin liquid

  • NDC Code(s): 58593-276-04
  • Packager: Efficient Laboratories Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 27, 2023

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

  • ACTIVE INGREDIENT

    Active Ingredients:(in each teaspoonful 2.5 ml.) Purpose

    Dextromethorphan Hydrobromide 5 mg ...................................... Cough Suppressant

    Guaifenesin 50 mg ................................................................... Expectorant

  • PURPOSE

    Purpose

    Cough Suppressant

    Expectorant

  • Uses

    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 drain bronchial tubes.
  • Warnings

    Do not use in child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional condition, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

  • Do not use

    Do not use in child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional condition, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

  • Keep out of reach of children.

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

  • Directions

    Do not give more than 6 doses in any 24 hours period  shake well before use  measure only with dosing cup provided  keep dosing cup with product  mL = milliliter

    Age Dose

    Children 6 to under 12 years of age 5 mL every 4 hours

    Children 4 to under 6 years of age 2.5 mL every 4 hours

    Children under 4 years of age Do not use

  • Inactive Ingredients:

    Inactive Ingredients: citric acid, elderberry fruit extract, glycerin, honey, maltodextrin, methylparaben, flavor, potassium sorbate as a preservative, propylparaben, propylene glycol, purified water, sodium chloride, sucralose and zinc sulfate.

  • QUESTIONS

    Questions or Comments?

    305-805-3456 Monday - Friday 9AM to 5PM EST

    www.efficientlabs.com

  • Stop use and ask a doctor if


     cough that occurs with too much phlegm (mucus)
     persistent or chronic cough, such as occurs with asthma or chronic bronchitis.

    These could be signs of a serious condition.

  • Ask a doctor before use if the child has

    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough, such as occurs with asthma or chronic bronchitis
  • Other Information

    • store this product between 15 to 30 °C (59 to 86 °F )
    • do not refrigerate
    • product color & flavor may vary due to natural honey

      Tamper-Evident Feature: do not use this product if printed security seal is torn, broken or missing.
  • Rompe Pechito

    Pack

  • INGREDIENTS AND APPEARANCE
    ROMPE PECHITO  DM FOR KIDS
    dextromethorphan hbr, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58593-276
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 2.5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN50 mg  in 2.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    AMERICAN ELDERBERRY (UNII: 7610Y219OC)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    HONEY (UNII: Y9H1V576FH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ZINC SULFATE (UNII: 89DS0H96TB)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58593-276-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/01/2023
    Labeler - Efficient Laboratories Inc (969044932)
    Registrant - Efficient Laboratories Inc (969044932)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rnv LLC118917568manufacture(58593-276)