Auromucus - childrens chest congestion solution

Drug facts

Active ingredient (in each5 mL (tsp) dose)

Guaifenesin, USP 100 mg

Purpose

Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

Ask a doctor before use if the child has

  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma

Stop use and ask a doctor if

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

  • 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&Cblue #1, FD&C red #40, flavor, glycerin,propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum.

Questions or comments?

1-855-274-4122You 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 chest congestion solution- Guaifenesin

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 58602-107
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Guaifenesin ( UNII: 495W7451VQ)( Guaifenesin - UNII: 495W7451VQ ) 100 mgin 5 mL

Inactive Ingredients

Ingredient Name Code
Anhydrous citric acid ( UNII: XF417D3PSL)
Edetate disodium ( UNII: 7FLD91C86K)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Grape ( UNII: 6X543N684K)
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 PURPLE Flavor GRAPE

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( 58602-107)

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

AUROHEALTH


NDC 58602-107-24


Compare to the active
ingredient in Children's

MUCINEX® Chest Congestion*

AuroMucus

Children's
Chest Congestion


Guaifenesin oral solution
100 mg per 5 mL
Expectorant


  • Chest Congestion
  • Breaks up Mucus

DOSING CUP INCLUDED
Alcohol-free

Grape
Flavor Syrup

4
FL OZ (118 mL)