AUROFLU DAY TIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL) SYRUP [AUROHEALTH LLC]

AUROFLU DAY TIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL) SYRUP [AUROHEALTH LLC]
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NDC 58602-162-33
Set ID 25ab3bb8-e5fb-4a81-8e28-b5d2d748e045
Category Human OTC Drug Label
Packager Aurohealth LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • Drug Facts

    Active ingredients

    (in each 30 mL (2 TBSP))

    Acetaminophen, USP 650 mg
    Dextromethorphan HBr, USP 20 mg
    Phenylephrine HCl, USP 10 mg

  • Purposes

    Pain Reliever/Fever Reducer
    Cough suppressant
    Nasal decongestant

  • Uses

    • temporarily relieves these symptoms due to a cold:
    • minor aches and pains
    • minor sore throat pain
    • headache
    • nasal and sinus congestion
    • cough due to minor throat and bronchial irritation
    • temporarily reduces fever
  • 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 daily 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

    • in a child under 12 years of age
    • if you are allergic to acetaminophen
    • 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.
  • Ask a doctor before use if you have

    • liver disease
    • 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 or emphysema
  • Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
  • When using this product

    • do not exceed recommended dosage
  • Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occurs
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • pain, cough or nasal congestion gets worse or lasts more than 7 days
    • 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 this and all drugs out of the reach of children.

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    • do not use more than directed
    • measure the dose correctly using the enclosed dosing cup
    • take every 4 hours in dosing cup provided, while symptoms persist
    • do not take more than 5 doses (150 mL) (10 TBSP) in 24 hours unless directed by a doctor
    • TBSP = Tablespoon, mL = milliliter

    Age
    Dose
    adults and children 12 years of age and over
    30 mL (2 TBSP)
    children under 12 years of age
    do not use

    Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

  • Other information

    • each 30 mL contains:sodium 17 mg
    • store at 20-25oC (68-77oF)
    • TAMPER EVIDENT: Do not use if printed seal over cap is broken or missing
  • Inactive ingredients

    acesulfame potassium, alcohol, anhydrous citric acid, edetate disodium, FD&C Blue no.1, FD&C Red #40, flavors, glycerin, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

    Questions or comments?

    1-855-274-4122

    *This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Theraflu® ExpressMax™ Daytime Severe Cold & Cough.

    PARENTS:
    Learn about teen medicine abuse
    www.StopMedicineAbuse.org

    TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL OVER CAP IS BROKEN OR MISSING.

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

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8.3 FL OZ (245.5 mL Bottle)

    AUROHEALTH

    Compare to the active ingredients in Theraflu® ExpressMax™ Daytime Severe Cold & Cough*

    NDC 58602-162-33
    AuroFlu

    Daytime Severe Cold & Cough
    Maximum Strength
    Per 4 hour dose.

    Each dose (per 30 mL) of Syrup contains:
    650 mg - ACETAMINOPHEN, USP (Pain Reliever/Fever Reducer)
    20 mg - DEXTROMETHORPHAN HBr, USP (Cough Suppressant)
    10 mg - PHENYLEPHRINE HCl, USP (Nasal Decongestant)

    • Nasal congestion
    • Headache
    • Sore throat pain
    • Fever
    • Cough
    • Body ache

    8.3 FL OZ (245.5 mL)

    Berry Flavor
    Alcohol Content: 10%

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8.3 FL OZ (245.5 mL Bottle)

  • INGREDIENTS AND APPEARANCE
    AUROFLU DAY TIME SEVERE COLD AND COUGH 
    acetaminophen, dextromethorphan hbr and phenylephrine hcl syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-162
    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
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ALCOHOL (UNII: 3K9958V90M)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    PINEAPPLE (UNII: 2A88ZO081O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MALTITOL (UNII: D65DG142WK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Product Characteristics
    ColorRED (Dark Red with Brown hue) Score    
    ShapeSize
    FlavorBERRY, PINEAPPLEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-162-33245.5 mL in 1 BOTTLE; Type 0: Not a Combination Product06/09/201607/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34106/09/201607/01/2022
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurohealth LLC078728447MANUFACTURE(58602-162)

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