AUROMUCUS - FAST MAXIMUM DM MAX- dextromethorphan hydrobromide and guaifenesin solution

AuroMucus - Fast Maximum DM MAX by

Drug Labeling and Warnings

AuroMucus - Fast Maximum DM MAX by is a Otc medication manufactured, distributed, or labeled by Aurohealth LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each 20 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 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

• 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 20-25°C (68-77°F)
• 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

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (180 mL Bottle)

AUROHEALTH

NDC: 58602-151-18

Compare to the active ingredients in

Mucinex® FAST-MAXTM

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-MAXTM

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)

INGREDIENTS AND APPEARANCE

AUROMUCUS - FAST MAXIMUM DM MAX 
dextromethorphan hydrobromide and guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-151
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
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	Score
Shape		Size
Flavor	CHERRY, STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-151-18	180 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/18/2015
2	NDC: 58602-151-21	266 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/18/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	07/18/2015

Labeler - Aurohealth LLC (078728447)

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