Auromucus - fast maximum dm max solution

Drug facts

Active ingredients (in each20 mL (4 tsp) dose)

Dextromethorphan HBr USP 20 mg
Guaifenesin USP 400 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 you get to sleep

Warnings

Do not use

  • for children under 12 years of age
  • if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Avoid foods or beverages that contain caffeine

Ask a doctor before use if you have

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

When using this product

  • do not use more than directed

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 condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • 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
  • Adults and children 12 years and older: 20 mL (4 tsp) orally every 4 hours, not to exceed 6 doses in 24 hours
  • Children under 12 years of age: do not use unless directed by a doctor

Other information

  • each 20 mL contains: sodium 12 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

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C red #40, flavors, glycerin, noncrystallizing sorbitol solution, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, 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 - fast maximum dm max solution- Dextromethorphan hydrobromide and guaifenesin

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 58602-151
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Dextromethorphan hydrobromide ( UNII: 9D2RTI9KYH)( Dextromethorphan - UNII: 7355X3ROTS ) 20 mgin 20 mL
Guaifenesin ( UNII: 495W7451VQ)( Guaifenesin - UNII: 495W7451VQ ) 400 mgin 20 mL

Inactive Ingredients

Ingredient Name Code
Anhydrous citric acid ( UNII: XF417D3PSL)
Edetate disodium ( UNII: 7FLD91C86K)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Strawberry ( UNII: 4J2TY8Y81V)
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 Flavor STRAWBERRY

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 58602-151-18 180mL in 1 BOTTLE 2015/07/18
2 NDC: 58602-151-21 266mL in 1 BOTTLE 2015/07/18

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part341 USA 2015/07/18

Labeler - Aurohealth LLC( 078728447)

Establishment

Name ID/FEI Business Operations
Aurohealth LLC 078728447 MANUFACTURE( 58602-151)

Package label-principal display panel 6 fl oz (180 ml bottle)

AUROHEALTH


NDC 58602-151-18


Compare to the active ingredients in

Mucinex® FAST-MAX TM

DMMAX*


MAXIMUM STRENGTH


AuroMucus

Fast Maximum

DM MAX


Each dose 20 mL (4 tsp) of oral solution contains:

20 mg Dextromethorphan HBr USP (Cough Suppressant)

400 mg - Guaifenesin USP (Expectorant)


  • Controls Cough
  • Relieves Chest Congestion
  • Thins & Loosens Mucus
  • 4 Hour Dosing

For Ages 12+ 6 FL OZ (180 mL)

Package label-principal display panel 9 fl oz (266 ml bottle)

AUROHEALTH


NDC 58602-151-21


Compare to the active ingredients in

Mucinex® FAST-MAX TM

DMMAX*


MAXIMUM STRENGTH


AuroMucus

Fast Maximum

DM MAX


Each dose 20 mL (4 tsp) of oral solution contains:

20 mg Dextromethorphan HBr USP (Cough Suppressant)

400 mg - Guaifenesin USP (Expectorant)


  • Controls Cough
  • Relieves Chest Congestion
  • Thins & Loosens Mucus
  • 4 Hour Dosing

For Ages 12+9 FL OZ (266 mL)