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AuroMucus - Fast Maximum Severe Congestion and Cough

Medically reviewed on July 18, 2018

Dosage form: solution
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 20mg in 20mL, GUAIFENESIN 400mg in 20mL, PHENYLEPHRINE HYDROCHLORIDE 10mg in 20mL
Labeler: Aurohealth LLC
NDC Code: 58602-112

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 - Fast Maximum Severe Congestion and Cough

Drug Facts

Active ingredients (in each 20 mL (4 tsp) dose)

Dextromethorphan HBr, USP 20 mg
Guaifenesin, USP 400 mg
Phenylephrine HCl, USP 10 mg

Purposes

Cough suppressant
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:
    • 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
    • nasal congestion due to a cold

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 Parkinson’s 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
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • 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
  • nervousness, dizziness or sleeplessness occur
  • symptoms do not get better within 7 days or occur with fever
  • cough comes back, or occurs with 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 right away (1-800-222-1222).

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 14 mg
  • Store at 20-25°C (68-77°F)
  • tamper evident: do not use if printed seal under cap is torn or missing
  • do not refrigerate
  • dosing cup provided

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, 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 6 FL OZ (177 mL Bottle)

AUROHEALTH


NDC 58602-112-18


Compare to the active ingredients in

Mucinex® FAST-MAXTM

Severe Congestion & Cough*


MAXIMUM STRENGTH**


AuroMucus

Fast Maximum

Severe Congestion & Cough


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

20 mg - Dextromethorphan HBr USP (Cough Suppressant)

400 mg - Guaifenesin USP (Expectorant)

10 mg - Phenylephrine HCl USP (Nasal Decongestant)


  • Controls Cough
  • Relieves Nasal & Chest Congestion
  • Thins & Loosens Mucus

For Ages 12+                         6 FL OZ (177 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 9 FL OZ (266 mL Bottle)

AUROHEALTH


NDC 58602-112-21


Compare to the active ingredients in

Mucinex® FAST-MAXTM

Severe Congestion & Cough*


MAXIMUM STRENGTH**


AuroMucus

Fast Maximum

Severe Congestion & Cough


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

20 mg – Dextromethorphan HBr USP (Cough Suppressant)

400 mg - Guaifenesin USP (Expectorant)

10 mg - Phenylephrine HCl USP (Nasal Decongestant)


  • Controls Cough
  • Relieves Nasal & Chest Congestion
  • Thins & Loosens Mucus

For Ages 12+                         9 FL OZ (266 mL)

AUROMUCUS - FAST MAXIMUM SEVERE CONGESTION AND COUGH 
dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-112
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
EDETATE DISODIUM 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
BERRY 
PINEAPPLE 
GLYCERIN 
PROPYLENE GLYCOL 
PROPYL GALLATE 
WATER 
SODIUM BENZOATE 
TRISODIUM CITRATE DIHYDRATE 
SORBITOL 
SUCRALOSE 
XANTHAN GUM 
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorBERRY, PINEAPPLEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:58602-112-18177 mL in 1 BOTTLE
2NDC:58602-112-21266 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/18/2015
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIOperations
Aurohealth LLC078728447MANUFACTURE(58602-112)

 
Aurohealth LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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