Label: PULMOVAC- guaifenesin, dextromethorphan hbr liquid

  • 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 August 28, 2013

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

  • ACTIVE INGREDIENT

    Active Ingredients (in each 5 mL tsp)

    Guaifenesin 100 mg…………………………............Expectorant

    Dextromethorphan HBR 10 mg…………………….Cough suppressant

  • Expectorant

    Cough Suppresant

  • INDICATIONS & USAGE

    Uses

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    • Do not exceed 6 doses in 24 hours.

    Adults and children over 12 years……………..2 teaspoonfuls (10 mL) every 4 hours

    Children 6 to under 12 years of age………….1 teaspoonful (5 mL) every 4 hours

    Children 2 to under 6 years of age………….1/2 teaspoonful (2.5 mL) every 4 hours

    Children under 2 years of age……………………consult your physician

  • OTHER SAFETY INFORMATION

    Other Information

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

  • INACTIVE INGREDIENT

    Inactive Ingredients

    citric acid, FD&C red #33, glycerin, methylparaben, propylene glycol, propylparaben, raspberry flavor, sucrose, water

  • PRINCIPAL DISPLAY PANEL

    Pulmovac Label

  • INGREDIENTS AND APPEARANCE
    PULMOVAC 
    guaifenesin, dextromethorphan hbr liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-031
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    RASPBERRY (UNII: 4N14V5R27W)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53145-031-061 in 1 CARTON
    1180 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/21/2012
    Labeler - Menper Distributors, Inc. (101947166)