AURO MUCUS - CHILDRENS COLD, COUGH AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]

AURO MUCUS - CHILDRENS COLD, COUGH AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]
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NDC 58602-157-24
Set ID 7f029c3b-1c5d-4d3c-8e52-48b3ad250aaa
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 10 mL)

    Acetaminophen, USP 325 mg
    Dextromethorphan HBr, USP 10 mg
    Guaifenesin, USP 200 mg
    Phenylephrine HCl, USP 5 mg

  • Purposes

    Pain reliever/fever reducer
    Cough suppressant
    Expectorant
    Nasal decongestant

  • Uses

    • temporarily relieves these common cold and flu symptoms:
      • nasal congestion 
      • stuffy nose
      • cough due to minor throat and bronchial irritation
      • the intensity of coughing
      • the impulse to cough to help your child get to sleep
      • minor aches and pains
      • sore throat
      • headache
    • temporarily reduces fever
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

    • more than 5 doses in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen

    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.
    • in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
  • Ask a doctor before use if your child has

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • a breathing problem such as chronic bronchitis
    • persistent or chronic cough such as occurs with asthma
    • cough that occurs with too much phlegm (mucus)
  • Ask a doctor or pharmacist before use if

    your child is taking the blood thinning drug warfarin

  • When using this product

    do not use more than directed (see Overdose warning)

  • Stop use and ask a doctor if

    • nervousness, dizziness or sleeplessness occur
    • pain, nasal congestion or cough gets worse or lasts more than 5 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.
  • Keep out of reach of children.

    Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.



  • Directions

    • this product does not contain directions or complete warnings for adult use
    • do not give more than directed (see Overdose warning)
    • do not give more than 5 doses in any 24-hour period
    • if needed, repeat dose every 4 hours while symptoms lasts
    • do not give more than 5 days unless directed by a doctor
    • shake well before using 
    • measure only with dosing cup provided
    • do not use dosing cup with other products
    • dose as follows or as directed by a doctor
    • mL = milliliter; tsp = teaspoon
    • children 6 to under 12 years of age: 10 mL in dosing cup provided
    • children under 6 years of age: do not use
  • Other information

    • each 10 mL contains: sodium 6 mg
    • tamper evident: do not use if printed seal under cap is torn or missing
    • Store at 20-25°C (68-77°F)
    • do not refrigerate
    • dosing cup provided.
  • Inactive ingredients

    anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, noncrystallizing sorbitol solution, propylene glycol, propyl gallate, 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 4 FL OZ (118 mL Bottle)

    AUROHEALTH

    NDC 58602-157-24

    Compare to the active ingredients in
    Children's Mucinex®
    Cold, Cough, & Sore Throat*

    Auro Mucus
    Children's
    Cold, Cough &
    Sore Throat



    Each dose 10 mL (2 tsp) of oral solution contains:
    Acetaminophen USP 325 mg (Pain Reliever/Fever Reducer)
    Dextromethorphan HBr USP 10 mg (Cough Suppressant)
    Guaifenesin USP 200 mg (Expectorant)
    Phenylephrine HCl USP 5 mg (Nasal Decongestant)



    • Cough
    • Sore Throat
    • Nasal Congestion
    • Chest Congestion
    • Control Cough
    • Soothes Sore Throat
    • Relieves Stuffy Nose
    • Relieves Chest Congestion

    Berry Blast Flavor Liquid

    DOSING CUP INCLUDED

    For Ages 6+        4 FL OZ (118 mL)
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (118 mL Bottle)

  • INGREDIENTS AND APPEARANCE
    AURO MUCUS - CHILDRENS COLD, COUGH AND SORE THROAT 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-157
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 10 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 10 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 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)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    PINEAPPLE (UNII: 2A88ZO081O)  
    MANGO (UNII: I629I3NR86)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorBLUE (Blue to Bluish Green) Score    
    ShapeSize
    FlavorBERRY, MANGO, PINEAPPLEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-157-24118 mL in 1 BOTTLE; Type 0: Not a Combination Product05/03/201604/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34105/03/201604/01/2022
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurohealth LLC078728447MANUFACTURE(58602-157)

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