Auromucus - childrens stuffy nose and cold solution

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 usein a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinsons disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your childs 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 20-25C (68-77F)
  • 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

Ingredients and appearance - Product information

Auromucus - childrens stuffy nose and cold solution- Guaifenesin and phenylephrine hydrochloride

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 58602-108
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Guaifenesin ( UNII: 495W7451VQ)( Guaifenesin - UNII: 495W7451VQ ) 100 mgin 5 mL
Phenylephrine hydrochloride ( UNII: 04JA59TNSJ)( Phenylephrine - UNII: 1WS297W6MV ) 2.5 mgin 5 mL

Inactive Ingredients

Ingredient Name Code
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

Color PINK (Pink to Red) Flavor PINEAPPLE

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part341 USA

Labeler - Aurohealth LLC( 078728447)

Establishment

Name ID/FEI Business Operations
Aurohealth LLC 078728447 MANUFACTURE( 58602-108)

Package label-principal display panel 4 fl oz (118 ml bottle)

AUROHEALTH


NDC 58602-108-24
Compare to the
active ingredients in
Childrens 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)