Label: CHILDRENS AUROTUSSIN COUGH AND COLD CF- 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 November 13, 2020

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

  • Active ingredients (in each 10 mL)

    Dextromethorphan HBr, USP 10 mg
    Guaifenesin, USP 100 mg
    Phenylephrine HCl, USP 5 mg

  • Purposes

    Cough suppressant
    Expectorant
    Nasal decongestant

  • Uses

      

    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
    • temporarily relieves these symptoms occurring with a cold:
    • nasal congestion
    • cough due to minor throat and bronchial irritation
  • Warnings

  • Do not use

    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.

  • Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • cough that occurs with too much phlegm (mucus)
    • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • Ask a doctor or pharmacist before use if you are

    taking any other oral nasal decongestant or stimulant.

    When using this product do not use more than directed.

  • Stop use and ask a doctor if

    • you get nervous, dizzy, or sleepless
    • symptoms do not get better within 7 days or are accompanied by fever
    • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.
      These could be signs of a serious condition.

  • If pregnant or breast-feeding,

    ask a health professional before use.

  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • Directions

    • measure only with dosing cup provided
    • keep dosing cup with product
    • mL = milliliter
    • do not take more than 6 doses in any 24-hour period


     Age
    Dose
    children under 6 years
    do not use
    children 6 to under
    12 years
    10 mL every 4 hours
    adults and children
    12 years and over
    20 mL every 4 hours

  • Other information

    • each 10 mL contains: sodium 7 mg
    • store at 20-25°C (68-77°F). Do not refrigerate
    • see bottom panel for lot number and expiration date
  • Inactive ingredients

    anhydrous citric acid, FD&C red #40 powder, flavor, glycerin, noncrystallizing sorbitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose.

  • Questions or Comments

    1-855-274-4122

    Distributed by: Aurohealth LLC.
    2572 Brunswick Pike,
    Lawrenceville, NJ 08648

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -4 FL OZ (118 mL Bottle)

    AUROHEALTH

    NDC 58602-154-24
    Compare to the active ingredients in
    Children's Robitussin®
    Cough & Cold CF*


    Ages 6 & Over
    Children's
    Aurotussin
    Cough & Cold CF


    Each 10 mL dose of oral solution contains:
    10 mg - Dextromethorphan HBr, USP (Cough Suppressant)
    100 mg - Guaifenesin, USP (Expectorant)
    5 mg - Phenylephrine HCI, USP (Nasal Decongestant)


    Relieves:

    • Cough
    • Chest Congestion/Mucus 
    • Stuffy Nose

    Non-Drowsy

    Grape Flavor                                4 FL OZ
                                                         (118 mL)

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL – 4FL OZ (118 mL Bottle)






  • INGREDIENTS AND APPEARANCE
    CHILDRENS AUROTUSSIN COUGH AND COLD CF 
    dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-154
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 10 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 10 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GRAPE (UNII: 6X543N684K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-154-241 in 1 CARTON06/30/201504/01/2022
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34106/30/201504/01/2022
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurohealth LLC078728447MANUFACTURE(58602-154)