Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

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AUROTUSSIN MUCUS PLUS CHEST CONGESTION (ORIGINAL) - guaifenesin liquid 
Aurohealth LLC

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.

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Drug Facts

Active ingredients (in each 10 mL)

Guaifenesin, USP 200 mg

Purposes

Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

Ask a doctor before use if you have


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

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or is accompanied by 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 right away (1-800-222-1222).

Directions

  • do not take more than 6 doses (12 tsp) in any 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • this adult product is not intended for use in children under 12 years of age
  • mL = milliliter

Age
Dose
adults and children
12 years and over
10 mL to 20 mL
every 4 hours
children under 12 years
do not use

Other information

  • each 10 mL contains: sodium 6 mg
  • store at 20-25°C (68-77°F)
  • alcohol-free

Inactive ingredients

anhydrous citric acid, caramel, FD&C red #40, flavor, glycerin, high fructose corn syrup, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate, xanthan gum.

Questions or Comments

1-855-274-4122

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

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -4 FL OZ (118 mL Bottle)

AUROHEALTH

NDC: 58602-155-24

Compare to the active ingredient in
Adult Robitussin
® Mucus+ Chest
Congestion*

ADULT

Aurotussin
Mucus + Chest
Congestion

ORIGINAL
Each 10 mL dose of oral solution contains:
200 mg - Guaifenesin, USP (Expectorant)

Relieves:

Mucus
Chest Congestion

Alcohol-free
                                                            4 FL OZ
For Ages 12 & Over                           (118 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL – 4FL OZ (118 mL Bottle)




AUROTUSSIN MUCUS PLUS CHEST CONGESTION (ORIGINAL) 
guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58602-155
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CARAMEL (UNII: T9D99G2B1R)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
RASPBERRY (UNII: 4N14V5R27W)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorRED (a clear reddish brown colored liquid) Score    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58602-155-241 in 1 CARTON06/26/2015
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 58602-155-201 in 1 CARTON06/26/2015
2236 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/26/2015
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurohealth LLC078728447MANUFACTURE(58602-155)

Revised: 11/2016
 
Aurohealth LLC


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