AUROMUCUS - CHILDRENS MULTI-SYMPTOM COLD - dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride solution 
Aurohealth LLC

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.

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AuroMucus Childrens  Multi-Symptom Cold

Drug Facts

Active ingredients (in each 5 mL (tsp) dose)

Dextromethorphan HBr, USP 5 mg
Guaifenesin, USP 100 mg
Phenylephrine HCl, USP 2.5 mg

Purposes

Cough Suppressant
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:
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing 
    • the impulse to cough to help your child get to sleep 
    • 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

When using this product

  • do not use more than directed

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

  • do not take more than 6 doses (30 mL) (6 tsp) in any 24-hour period
  • 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

Age
Dose
Children 6 years to under 12 years
10 mL (2 tsp) orally every 4 hours, not to exceed 6 doses in 24 hours
Children 4 years to under 6 years
5 mL (1 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

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 58602-138-24 Compare to the active ingredients in Children’s Mucinex® Multi-Symptom Cold* 


AuroMucus
 Children's Multi-Symptom Cold

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

  • Stuffy Nose

  • Cough

  • Chest Congestion

  • Breaks up Mucus

Very Berry Flavor Syrup DOSING CUP INCLUDED 

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

AUROMUCUS - CHILDRENS MULTI-SYMPTOM COLD 
dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-138
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
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)  
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, MANGOImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-138-241 in 1 CARTON05/25/201512/09/2020
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 FINALpart34105/25/201512/09/2020
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurohealth LLC078728447MANUFACTURE(58602-138)

Revised: 12/2020
 
Aurohealth LLC