Label: NOVALGINA PEDIATRICO COUGH AND COLD PEDIATRICO- dextromethorphan hbr, guaifenesin, phenylephrine hcl 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 October 2, 2023

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

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredients:(in each 1 ml.)Purpose

    Dextromethorphan Hydrobromide 7.5 mg .......................

    Cough Suppressant

    Guaifenesin 88 mg......................................................

    Expectorant

    Phenylephrine HCl 2.5 mg.......................................................

    Decongestant
  • PURPOSE

    Uses:

    • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make the cough more productive.
    • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold. or inhaled irritants
    • the intensity of coughing
    • The impulse to cough to help your child get to sleep
    • nasal congestion due to a cold
    • stuffy nose
  • Warnings

    in a child who is taking 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

    Do not Use

    in a child who is taking 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

    Ask a Doctor before use

    Ask a doctor before use if the child has

    • Heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • persistent or chronic cough such as occurs with asthma
    • cough that occurs with too much phlegm (mucus)

    When using this product

    When using this product do not use more that directed

    Stop use and ask a doctor

    If nervousness, dizziness, or sleeplessness occur symptoms do not get better within 7 days or occur with fever cough last more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

    Keep out of reach of children.

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

  • INDICATIONS & USAGE

    Other Information:

    Each 1 mls

    Store between 15 - 30 degrees Celsius (59 - 86 Fahrenheit).


  • Other Information:

    • Store between 15 - 30 degrees Celsius (59 - 86 Fahrenheit).
    • Tamper Evident Feature: Do not use if there is evidence of tampering
  • Inactive Ingredient

    Citric Acid, FD&C red no. 40, artificial flavors, glycerine, high fructose corn syrup, Hydroxyethyl Cellulose, methylparaben, propylene glycol, Propylparaben, purified water, sodium citrate, sorbitol solution, sucralose.

  • Dosage and Administration

    Do not exceed recommended dose. Measure with the dosage device provided

    Children 6 to under 12 years of age 2 ml every 6-8 hours
    Children 2 to under 6 years of age 1 ml every 6-8 hours
    Children under 2 years of age Consult a doctor

  • PRINCIPAL DISPLAY PANEL

    labelPack

  • INGREDIENTS AND APPEARANCE
    NOVALGINA PEDIATRICO COUGH AND COLD  PEDIATRICO
    dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83057-0002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE7.5 mg  in 1 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN88 mg  in 1 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83057-0002-21 in 1 CARTON02/01/2023
    160 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/01/2023
    Labeler - HBC Pharma LLC (063580631)
    Establishment
    NameAddressID/FEIBusiness Operations
    GADAL Laboratories, Inc841305639manufacture(83057-0002)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!