AuroMucus - Fast Maximum Severe Congestion and Cough

Manufacturer
Aurohealth LLC
Effective date
2020-11-26
Label type
Human OTC Drug Label
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:03:50

Label at a glance#

ProductAuroMucus - Fast Maximum Severe Congestion and Cough
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure14 sections

Indications and 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

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

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

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

Purposes

OTC - PURPOSE SECTION

Cough suppressant
Expectorant
Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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

OTC - ASK DOCTOR SECTION

  • 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

OTC - WHEN USING SECTION

  • do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

1-855-274-4122

You may also report side effects to this phone number.

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Mucinex® FAST-MAX® Severe Congestion & Cough
** per 4 hour dose

Distributed by:
Aurohealth LLC.
2572 Brunswick Pike,
Lawrenceville, NJ 08648

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (177 mL Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58602-505-18
PrimaryHealth
COMPARE TO Mucinex® 
FAST-MAX® Severe Congestion &
Cough Active Ingredients*


MAXIMUM STRENGTH**

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 6 FL OZ (177 mL Bottle)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (177 mL Bottle)

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58602-50558602-505-18

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
7c469f18-e08e-4fb9-8cf5-9d4d9936e82085dbe638-9e2d-4889-8a3e-8417ad588aae2020-11-26WarningsExact identifier
spl id: 7c469f18-e08e-4fb9-8cf5-9d4d9936e820
spl set id: 85dbe638-9e2d-4889-8a3e-8417ad588aae

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.