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AuroMucus - Childrens Stuffy Nose and Cold

Dosage form: solution
Ingredients: GUAIFENESIN 100mg in 5mL, PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 5mL
Labeler: Aurohealth LLC
NDC Code: 58602-108

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.

AuroMucus Children's Stuffy Nose and Cold

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)

AUROMUCUS - CHILDRENS STUFFY NOSE AND COLD 
guaifenesin and phenylephrine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-108
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
EDETATE DISODIUM 
FD&C RED NO. 40 
BERRY 
MANGO 
PINEAPPLE 
GLYCERIN 
PROPYLENE GLYCOL 
PROPYL GALLATE 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
SORBITOL 
SUCRALOSE 
XANTHAN GUM 
Product Characteristics
ColorPINK (Pink to Red) Score    
ShapeSize
FlavorBERRY, MANGO, PINEAPPLEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:58602-108-241 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/19/2015
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIOperations
Aurohealth LLC078728447MANUFACTURE(58602-108)

Revised: 05/2015
 
Aurohealth LLC

← See all AuroMucus - Childrens Stuffy Nose and Cold brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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