Label: AUROPHEN COLD MULTI SYMPTOM- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride 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 31, 2019

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

  • Drug Facts

    Active ingredients (in each 15 mL)                           
    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Doxylamine succinate 6.25 mg
    Phenylephrine HCl 5 mg

  • Purpose

    Pain reliever/fever reducer
    Cough suppressant
    Antihistamine
    Nasal decongestant

  • Uses

    • temporarily relieves these common cold/flu symptoms:
      • minor aches and pains
      • headache
      • sore throat
      • nasal congestion
      • runny nose and sneezing
      • cough
      • sinus congestion and pressure
    • helps clear nasal passages
    • relieves cough to help you sleep
    • 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 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.
    • if you have ever had an allergic reaction to this product or any of its ingredients
  • 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
    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • persistent or chronic cough such as occurs with smoking, asthma or emphysema
    • cough that occurs with too much phlegm (mucus)
  • Ask a doctor or pharmacist before use if you are

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

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

    • nervousness, dizziness, or sleeplessness occur
    • 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: 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

    • do not take more than directed (see overdose warning)
    • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
    • mL = milliliter
    adults and children 12 years and over
    • take 30 mL in the dosing cup provided every 4 hours while symptoms last
    • do not take more than 150 mL in 24 hours, unless directed by a doctor
    children under 12 years
    ask a doctor
  • Other information

    • each 15 mL contains: sodium 5 mg
    • store at 20-25˚C (68-77˚F). Do not refrigerate.
    • do not use if printed shrinkband is missing or broken
    • see back label for lot number and expiration date
  • Inactive ingredients

    alcohol, anhydrous citric acid, FD & C Blue #1, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose

  • Questions or Comments?

    1-855-274-4122

    DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN


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

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (240 mL Bottle)

    AUROHEALTH

    NDC 58602-127-20

    Compare to the active
    ingredients in TYLENOL®
    COLD MULTI-SYMPTOM Liquid night time cool burstTM*

    NIGHT TIME

    Cool Blast

    AUROPHEN

    COLD MULTI-SYMPTOM

    For Adults

    Acetaminophen - Pain Reliever/Fever Reducer

    Phenylephrine HCl - Nasal Decongestant

    Dextromethorphan HBr - Antitussive

    Doxylamine Succinate - Antihistamine

    • Headache, Fever, Sore Throat
    • Nasal Congestion
    • Cough
    • Runny Nose                                 Alcohol 0.5%

    8 FL OZ

    (240 mL)

    Liquid

    Do not use if printed shrinkband is missing or broken.

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (240 mL Bottle)

  • INGREDIENTS AND APPEARANCE
    AUROPHEN COLD MULTI SYMPTOM 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-127
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 15 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 15 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg  in 15 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorBLUE (Blue to greenish blue) Score    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-127-201 in 1 CARTON04/30/2015
    1240 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34104/30/2015
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurohealth LLC078728447MANUFACTURE(58602-127)