AUROMUCUS - CHILDRENS STUFFY NOSE AND COLD (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]

AUROMUCUS - CHILDRENS STUFFY NOSE AND COLD (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]
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NDC 58602-108-24
Set ID 79ec8f43-b48f-437b-87a8-2b1ab1d978b0
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 5 mL (tsp) dose)

    Guaifenesin, USP 100 mg

    Phenylephrine HCl, USP 2.5 mg

  • Purposes

    Expectorant
    Nasal Decongestant

  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
    • temporarily relieves:
      • nasal congestion due to a cold
      • stuffy nose
  • Warnings

    Do not use 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.

    Avoid foods or beverages that contain caffeine.

  • Ask a doctor before use if the child has

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough such as occurs with asthma
  • Do not exceed recommended dosage.

    If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor

  • Stop use and ask a doctor if

    • your child gets nervous, dizzy or sleepless
    • symptoms do not get better within 7 days or occur with fever
    • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

    These could be signs of a serious illness.

  • Keep out of reach of children.

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

  • Directions

    • measure only with dosing cup provided
    • do not use dosing cup with other products
    • mL= milliliter; tsp = teaspoon

    Age
    Dose
    Children 4 years to 6 years
    5 mL (1 tsp) orally every 4 hours, not to exceed 6 doses in 24 hours
    Children 6 years to 12 years
    10 mL (2 tsp) orally every 4 hours, not to exceed 6 doses in 24 hours
    Children under 4 years
    do not use unless directed by a doctor
  • Other information

    • each 5 mL contains: sodium 3 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
    • see bottom panel for lot number and expiration date
  • Inactive ingredients

    anhydrous citric acid, edetate disodium, FD&C red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum.

  • Questions or Comments?

    1-855-274-4122
    You may also report side effects to this phone number.


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

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

    AUROHEALTH


    NDC 58602-108-24
    Compare to the
    active ingredients in
    Children’s Mucinex®
    Stuffy Nose & Cold*

    AuroMucus
    Children's
    Stuffy Nose and Cold

    Each dose 5 mL (1 tsp) of oral solution contains:
    Guaifenesin, USP 100 mg
    Phenylephrine HCl, USP 2.5 mg

    Expectorant
    Nasal decongestant

    • Stuffy Nose
    • Chest congestion
    • Breaks up mucus

    DOSING CUP
    INCLUDED
    Alcohol-free

    For Ages 4+

    Mixed Berry
    Flavor Syrup

    4 FL OZ (118 mL)
    Figure 1

  • INGREDIENTS AND APPEARANCE
    AUROMUCUS - CHILDRENS STUFFY NOSE AND COLD 
    guaifenesin and phenylephrine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-108
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MANGO (UNII: I629I3NR86)  
    PINEAPPLE (UNII: 2A88ZO081O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorPINK (Pink to Red) Score    
    ShapeSize
    FlavorBERRY, MANGO, PINEAPPLEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-108-241 in 1 CARTON05/19/201505/01/2022
    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 FINALpart34105/19/201505/01/2022
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurohealth LLC078728447MANUFACTURE(58602-108)

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