Label: AUROTUSSIN MAXIMUM STRENGTH DAYTIME AND NIGHTTIME COUGH RELIEF- dextromethorphan hbr, guaifenesin, dextromethorphan hbr, doxylamine succinate kit

  • NDC Code(s): 58602-116-24, 58602-159-24, 58602-160-37
  • Packager: Aurohealth LLC
  • 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 December 5, 2019

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

  • Drug Facts - Day Time

    Active ingredients (in each 10 mL)

    Dextromethorphan HBr, USP 20 mg
    Guaifenesin, USP 400 mg

  • Drug Facts - Night Time

    Active ingredients (in each 10 mL)

    Dextromethorphan HBr, USP 30 mg
    Doxylamine Succinate, USP 12.5 mg

  • Purposes - Day Time

    Cough suppressant
    Expectorant

  • Purposes - Night Time

    Cough suppressant

    Antihistamine

  • Uses - Day Time

    • 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
  • Uses - Night Time

    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
    • controls the impulse to cough to help you sleep
  • Warnings - Day Time

    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.

  • Warnings - Night Time

    Do not use

    • to sedate a child or to make a child sleepy
    • 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 - Day Time

    • 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 before use if you have - Night Time

    • trouble urinating due to an enlarged prostate gland
    • glaucoma
    • a cough that occurs with too much phlegm (mucus)
    • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • Ask a doctor or pharmacist before use if you are - Night Time

    taking sedatives or tranquilizers

  • When using this product - Night Time

    • do not use more than directed
    • marked drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children
  • Stop use and ask a doctor if - Day Time

    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.

  • Stop use and ask a doctor if - Night Time

    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, - Day Time

    ask a health professional before use.

  • If pregnant or breast-feeding, - Night Time

    ask a health professional before use.

  • Keep out of reach of children. - Day Time

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

  • Keep out of reach of children. - Night Time

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

  • Directions - Day Time

    • shake well before using
    • do not take more than 6 doses (12 tsp) in any 24-hour period
    • measure only with dosing cup provided
    • keep dosing cup with product
    • mL = milliliter
    • this adult product is not intended for use in children under 12 years of age
    Age
    Dose
    adults and children 12 years and over
    10 mL every 4 hours
    children under 12 years
    do not use
  • Directions - Night Time

    • measure only with dosing cup provided
    • keep dosing cup with product
    • mL = milliliter
    • do not take more than 4 doses (8 tsp) in any 24-hour period
    • this adult product is not intended for use in children under 12 years of age
    • shake well before using
    age
    dose
    adults and children 12 years and over
    10 mL every 6 hours
    children under 12 years
    do not use
  • Other information - Day Time

    • each 10 mL contains: sodium 8 mg
    • store at 20-25°C (68-77°F). Do not refrigerate
    • alcohol-free

  • Other information - Night Time

    • each 10 mL contains: sodium 7 mg
    • store at 20-25°C (68-77°F).
    • alcohol-free
  • Inactive ingredients - Day Time

    anhydrous citric acid, carboxymethylcellulose sodium, D&C red #33, FD&C red #40, flavors, glycerin, high fructose corn syrup, menthol, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

  • Inactive ingredients - Night Time

    anhydrous citric acid, FD&C red # 40, flavors, glycerin, high fructose corn syrup, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, xanthan gum

  • Questions or comments?

    1-855-274-4122

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

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (236 mL Bottle)

    AUROHEALTH

    NDC 58602-160-37

    Compare to the active ingredients in
    Adult

    Robitussin®

    Peak Cold
    Maximum strength
    Cough + Chest
    Congestion DM*

    ADULT

    Aurotussin

    PEAK COLD

    MAXIMUM STRENGTH

    Cough + Chest

    Congestion DM

    Each 10 mL dose of oral solution contains:

    20 mg - Dextromethorphan HBr, USP (Cough Suppressant)

    400 mg - Guaifenecin, USP (Expectorant)

    Relieves:

    • Cough
    • Mucus

    DM

    MAX

    Cherry Flavor

    Non-Drowsy

    4 FLOZ

    (118 mL)

    For Ages 12 & Over

    Compare to the active ingredients
    in Adult Robitussin® Maximum

    Strength Nighttime Cough DM*

    ADULT

    Aurotussin

    MAXIMUM STRENGTH

    Nighttime Cough DM

    Each 10 mL dose of oral solution contains:

    30 mg - Dextromethorphan HBr, USP (Cough Suppressant)

    12.5 mg - Doxylamine Succinate, USP (Antihistamine)

    Relieves:

    • Cough
    • Itchy Throat
    • Runny Nose

    Max Strength

    Nighttime Cough Control

    DM NIGHTTIME MAX

    Pineapple Flavor

    4 FL OZ (118 mL)

    For Ages 12 & Over

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (236 mL Bottle)

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

    AUROHEALTH

    NDC 58602-116-24

    Compare to the active ingredients in
    Adult
    Robitussin® Peak Cold
    Maximum strength Cough + Chest
    Congestion DM*

    ADULT

    Aurotussin

    PEAK COLD

    MAXIMUM STRENGTH

    Cough + Chest Congestion DM

    Each 10 mL dose of oral solution contains:

    20 mg - Dextromethorphan HBr, USP (Cough Suppressant)

    400 mg - Guaifenesin, USP (Expectorant)

    Relieves:

    • Cough
    • Mucus

    DM

    MAX

    Cherry Flavor

    Non-Drowsy

    4 FLOZ

    (118 mL)

    For Ages 12 & Over

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

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

    AUROHEALTH

    NDC 58602-159-24

    Compare to the active ingredients in

    Adult Robitussin® Maximum Strength

    Nighttime Cough DM*

    ADULT

    Aurotussin

    MAXIMUM STRENGTH

    Nighttime Cough DM

    Each 10 mL dose of oral solution contains:

    30 mg - Dextromethorphan HBr, USP (Cough Suppressant)

    12.5 mg - Doxylamine Succinate, USP (Antihistamine)

    Relieves:

    • Cough
    • Itchy Throat
    • Runny Nose

    Max Strength Nighttime Cough Control

    DM

    NIGHTTIME

    MAX

    Pineapple Flavor                         4 FL OZ

    For Ages 12 & Over                   (118 mL)

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

  • INGREDIENTS AND APPEARANCE
    AUROTUSSIN MAXIMUM STRENGTH DAYTIME AND NIGHTTIME COUGH RELIEF 
    dextromethorphan hbr, guaifenesin, dextromethorphan hbr, doxylamine succinate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-160
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-160-371 in 1 CARTON; Type 0: Not a Combination Product05/27/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 118 mL
    Part 21 BOTTLE 118 mL
    Part 1 of 2
    AUROTUSSIN PEAK COLD MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM 
    dextromethorphan hbr, guaifenesin liquid
    Product Information
    Item Code (Source)NDC:58602-116
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 10 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    CHERRY (UNII: BUC5I9595W)  
    VANILLA (UNII: Q74T35078H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorRED (a red colored liquid) Score    
    ShapeSize
    FlavorCHERRY, VANILLAImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-116-241 in 1 CARTON
    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 FINALpart34105/27/2016
    Part 2 of 2
    ADULT AUROTUSSIN MAXIMUM STRENGTH NIGHTTIME COUGH DM 
    dextromethorphan hbr, doxylamine succinate liquid
    Product Information
    Item Code (Source)NDC:58602-159
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 10 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ORANGE (UNII: 5EVU04N5QU)  
    PINEAPPLE (UNII: 2A88ZO081O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorRED (a clear red colored liquid) Score    
    ShapeSize
    FlavorMENTHOL, ORANGE, PINEAPPLEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-159-241 in 1 CARTON
    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 FINALpart34105/27/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34105/27/2016
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurohealth LLC078728447MANUFACTURE(58602-160)