ADULT AUROTUSSIN MAXIMUM STRENGTH NIGHTTIME COUGH DM - dextromethorphan hbr, doxylamine succinate 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)

Dextromethorphan HBr, USP 30 mg
Doxylamine Succinate, USP 12.5 mg

Purposes

Cough suppressant
Antihistamine

Uses

Warnings

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

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


age
dose
adults and children 12 years and over
10 mL every 6 hours
children under 12 years
do not use


Other information

Inactive ingredients

anhydrous citric acid, FD&C red #40, flavors, glycerin, high fructose corn syrup, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, 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 58602-159-24

Compare to the active ingredients in
Adult Robitussin
® Maximum Strength
Nighttime Cough DM*

ADULT
Aurotussin
MAXIMUM STRENGTH

Nighttime Cough DM

Each 10 mL dose of oral solution contains:
30 mg - Dextromethorphan HBr, USP (Cough Suppressant)
12.5 mg - Doxylamine Succinate, USP (Antihistamine)

Relieves:

Cough
Itchy Throat
Runny Nose
Max Strength Nighttime Cough Control
DM
NIGHTTIME
MAX

Pineapple Flavor                                4 FL OZ
For Ages 12 & Over                           (118 mL)

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

ADULT AUROTUSSIN MAXIMUM STRENGTH NIGHTTIME COUGH DM 
dextromethorphan hbr, doxylamine succinate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-159
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 10 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
ORANGE (UNII: 5EVU04N5QU)  
PINEAPPLE (UNII: 2A88ZO081O)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
LEVOMENTHOL (UNII: BZ1R15MTK7)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorRED (a clear red colored liquid) Score    
ShapeSize
FlavorMENTHOL, ORANGE, PINEAPPLEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-159-241 in 1 CARTON05/02/2016
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/02/2016
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurohealth LLC078728447MANUFACTURE(58602-159)

Revised: 5/2016
Document Id: e64d9ff3-9c11-4a4a-923f-853a33ac6427
Set id: e64d9ff3-9c11-4a4a-923f-853a33ac6427
Version: 1
Effective Time: 20160502
 
Aurohealth LLC