Label: LIMPIA PECHO- dextromethorphan hbr, guaifenesin liquid

  • NDC Code(s): 54859-011-04
  • Packager: Llorens Pharmaceutical International Division, 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 June 9, 2019

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  • ACTIVE INGREDIENT

    In each teaspoonful, 5 mL

    Dextromethorphan HBr - 10 mg

    Guaifenesin - 100 mg

  • PURPOSE

    Purpose

    Cough Suppressant

    Expectorant

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves cough as may occur with the common cold
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
  • WARNINGS

    Warnings

    Do not exceed recommended dosage

    Do not use

    • if you are now taking a 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 prduct.

    Ask a doctor before use if you have 

    • a cough that is accompanied by excessive phlegm (mucus)
    • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

    Stop use and ask a dotor if

    • cough persist for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. These may be signs of a serious condition
  • PREGNANCY

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions

    • use dosage cup provided
    • Do not exceed 6 doses in any 24 hour period or as directed by a doctor
     Age Dose
     Adults and children over 12 years of age 10 mL (2 tsp) every 4 hours
     Children 6 to under 12 years of age 5 mL (1 tsp) every 4 hours
     Children under 6 Ask a doctor

  • INACTIVE INGREDIENT

    Inactive ingredients artificial and natural flavor, citric acid, methol, methylparaben, propylened glycol, propylparaben, purified water, sodium citrate, and sucralose.

  • QUESTIONS

    Questions or Comments? 1-866-595-5598

  • PRINCIPAL DISPLAY PANEL

    LipiaPecho

  • INGREDIENTS AND APPEARANCE
    LIMPIA PECHO 
    dextromethorphan hbr, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-011
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54859-011-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/01/2019
    Labeler - Llorens Pharmaceutical International Division, Inc. (037342305)
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