Label: AUROQUIL SEVERE COLD AND FLU NIGHTTIME RELIEF- acetaminophen, phenylephrine hcl, doxylamine succinate and dextromethorphan hbr solution

  • NDC Code(s): 58602-148-16, 58602-148-20
  • 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 November 28, 2019

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

  • Drug Facts

  • PURPOSE

    Active ingredients (in each 30 mL dose cup)                             Purpose

    Acetaminophen USP 650 mg .............................................. Pain reliever/fever reducer
    Dextromethorphan HBr USP 20 mg ............................................... Cough suppressant
    Doxylamine succinate USP 12.5 mg ........................................................ Antihistamine
    Phenylephrine HCl USP 10 mg ...................................................... Nasal decongestant

  • Uses

    temporarily relieves common cold/flu symptoms:

    • nasal congestion
    • sinus congestion & pressure 
    • cough due to minor throat & bronchial irritation
    • cough to help you sleep
    • minor aches & pains
    • headache
    • fever
    • sore throat
    • runny nose & sneezing
    • reduces swelling of nasal passages
    • temporarily restores freer breathing through the nose
    • promotes nasal and/or sinus drainage
  • Warnings

    Liver warning: This product contains acetaminophen.

    Severe liver damage may occur if you take

    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

  • Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • 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.
    • to make a child sleep
  • Ask a doctor before use if you have

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • 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
    • trouble urinating due to enlarged prostate gland
    • a sodium-restricted diet
  • Ask a doctor or pharmacist before use if you are

    • taking sedatives or tranquilizers
    • taking the blood thinning drug warfarin
  • When using this product

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

    • you get nervous, dizzy or sleepless
    • pain, nasal congestion, or cough gets worse or lasts more than 7 days 
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • cough comes back or occurs with rash or headache that lasts.

    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.

    Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    • take only as directed – see Overdose warning
    • use dose cup or tablespoon (TBSP)
    • do not exceed 4 doses (120 mL) (8 TBSP) per 24 hours
    • mL = milliliter; TBSP = tablespoon
    adults & children 12 years & over
    30 mL (2 TBSP) every 4 hours
    children 4 to under 12 years
    ask a doctor
    children under 4 years
    do not use
    • when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
  • Other information

    • each 30 mL dose cup contains: sodium 95 mg
    • store at 20° to 25°C (68° to 77°F)
  • Inactive ingredients

    anhydrous citric acid, flavors, FD&C Blue no. 1, FD&C Red no. 40, glycerin, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, 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 (237 mL Bottle)

    AUROHEALTH

    Compare to the active
    ingredients in the Vicks® NyQuil®
    SEVERE Cold & Flu Relief Liquid*

    NDC 58602-148-20

    Maximum Strength

    AuroQuil
    SEVERE
    COLD & FLU
    Nighttime Relief

    Each dose (per 30 mL) (2 TBSP) of oral solution contains:
    650 mg - Acetaminophen USP (Pain reliever/fever reducer)
    10 mg – Phenylephrine HCl USP (Nasal decongestant)
    12.5 mg - Doxylamine succinate USP (Antihistamine)
    20 mg - Dextromethorphan HBr USP (Cough suppressant)


    • Headache, Fever, Sore Throat, Minor Aches & Pains
    • Nasal/Sinus Congestion & Sinus Pressure
    • Sneezing, Runny Nose
    • Cough

    Berry Flavor                             8 FL OZ (237 mL)
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (237 mL Bottle)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (354 mL Bottle)

    AUROHEALTH

    Compare to the active
    ingredients in the Vicks® NyQuil®
    SEVERE Cold & Flu Relief Liquid*

    NDC 58602-148-16

    Maximum Strength

    AuroQuil
    SEVERE
    COLD & FLU
    Nighttime Relief

    Each dose (per 30 mL) (2 TBSP) of oral solution contains:
    650 mg - Acetaminophen USP (Pain reliever/fever reducer)
    10 mg – Phenylephrine HCl USP (Nasal decongestant)
    12.5 mg - Doxylamine succinate USP (Antihistamine)
    20 mg - Dextromethorphan HBr USP (Cough suppressant)


    • Headache, Fever, Sore Throat, Minor Aches & Pains
    • Nasal/Sinus Congestion & Sinus Pressure
    • Sneezing, Runny Nose
    • Cough

    Berry Flavor                             12 FL OZ (354 mL)
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (354 mL Bottle)

  • INGREDIENTS AND APPEARANCE
    AUROQUIL SEVERE COLD AND FLU NIGHTTIME RELIEF 
    acetaminophen, phenylephrine hcl, doxylamine succinate and dextromethorphan hbr solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-148
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 30 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorBERRY (Prosweet) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-148-20237 mL in 1 BOTTLE; Type 0: Not a Combination Product05/31/2015
    2NDC:58602-148-16354 mL in 1 BOTTLE; Type 0: Not a Combination Product05/31/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34105/31/2015
    Labeler - Aurohealth LLC (078728447)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurohealth LLC078728447MANUFACTURE(58602-148)