Auromucus - childrens cough solution

Drug facts

Active ingredients (in each5 mL (tsp) dose)

Dextromethorphan HBr, USP5 mg
Guaifenesin, USP 100 mg

Purposes

Cough suppressant
Expectorant

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 childget to sleep

Warnings

Do not usein 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 orpharmacist before giving this product. Avoid foods or beverages that contain caffeine

Ask a doctor before use if the child has

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

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, D&C red #33, edetate disodium, FD&C red #40, flavor, glycerin,propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum.

Questions or comments

1-855-274-4122

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 cough solution- Dextromethorphan hydrobromide and guaifenesin

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 58602-106
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Dextromethorphan hydrobromide ( UNII: 9D2RTI9KYH)( Dextromethorphan - UNII: 7355X3ROTS ) 5 mgin 5 mL
Guaifenesin ( UNII: 495W7451VQ)( Guaifenesin - UNII: 495W7451VQ ) 100 mgin 5 mL

Inactive Ingredients

Ingredient Name Code
Anhydrous citric acid ( UNII: XF417D3PSL)
D&c red no. 33 ( UNII: 9DBA0SBB0L)
Edetate disodium ( UNII: 7FLD91C86K)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Cherry ( UNII: BUC5I9595W)
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 RED (red to pink) Flavor CHERRY

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( 58602-106)

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

AUROHEALTH


NDC 58602-106-24


Compare to the active
ingredientsin Children's
Mucinex® Cough*

AuroMucus

Children's
Cough

Each dose5 mL (1 tsp) of oral solution contains:

Dextromethorphan HBr USP 5 mg

Guaifenesin, USP 100 mg

Expectorant
Cough Suppressant

  • Cough
  • Chest Congestion
  • Breaks up Mucus

Cherry
Flavor Syrup

Alcohol-free DOSING CUP INCLUDED

4
FL OZ (118 mL)