AUROQUIL COUGH NIGHTTIME COUGH RELIEF - dextromethorphan hbr and doxylamine succinate solution 
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 30 mL dose cup)                           Purpose
 Dextromethorphan HBr USP 30 mg ............................................. Cough suppressant
Doxylamine succinate USP 12.5 mg .............................................. Antihistamine

Uses

temporarily relieves cold symptoms:

  • cough
  • runny nose and sneezing

Warnings

Do not use

  • 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.
  • to make a child sleep

Ask a doctor before use if you have

  • glaucoma
  • excessive phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • trouble urinating due to enlarged prostate gland
  • a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts.

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

  • use dose cup or tablespoon (TBSP)
  • do not exceed 4 doses (120 mL) (8 TBSP) per 24 hours
  • mL = milliliter; TBSP = tablespoon
adults and children 12 years and over
30 mL (2 TBSP) every 6 hours
children 4 to under 12 years
ask a doctor
children under 4 years
do not use
  • when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Other information

  • each 30 mL dose cup contains: sodium 35 mg
  • store at 20° to 25°C (68° to 77°F)

Inactive ingredients

alcohol, anhydrous citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions or Comments?

1-855-274-4122

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

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

AUROHEALTH

Compare to the active ingredients
in Vicks® NyQuil® Cough*

NDC 58602-132-20

AuroQuil
COUGH
Nighttime Cough Relief

Each dose (per 30 mL) (2 TBSP) of oral solution contains:
30 mg - Dextromethorphan HBr USP (Cough suppressant)
12.5 mg - Doxylamine succinate USP (Antihistamine)


  • Cough
  • Sneezing, Runny Nose

Alcohol 10%                           Cherry Flavor                        6 FL OZ (177 mL)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (177 mL Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (236 mL Bottle)

AUROHEALTH

Compare to the active ingredients
in Vicks® NyQuil® Cough*

NDC 58602-132-18

AuroQuil
COUGH
Nighttime Cough Relief

Each dose (per 30 mL) (2 TBSP) of oral solution contains:
30 mg - Dextromethorphan HBr USP (Cough suppressant)
12.5 mg - Doxylamine succinate USP (Antihistamine)


  • Cough
  • Sneezing, Runny Nose

Alcohol 10%                           Cherry Flavor                        8 FL OZ (236 mL)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (236 mL Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (354 mL Bottle)

AUROHEALTH

Compare to the active ingredients
in Vicks® NyQuil® Cough*

NDC 58602-132-16

AuroQuil
COUGH
Nighttime Cough Relief

Each dose (per 30 mL) (2 TBSP) of oral solution contains:
30 mg - Dextromethorphan HBr USP (Cough suppressant)
12.5 mg - Doxylamine succinate USP (Antihistamine)


  • Cough
  • Sneezing, Runny Nose

Cherry Flavor

Alcohol 10%
                                     12 FL OZ  (354 mL)

                                                                       
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (354 mL Bottle)

AUROQUIL COUGH NIGHTTIME COUGH RELIEF 
dextromethorphan hbr and doxylamine succinate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-132
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
CHERRY (UNII: BUC5I9595W)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-132-20177 mL in 1 BOTTLE; Type 0: Not a Combination Product07/27/201509/01/2021
2NDC:58602-132-18236 mL in 1 BOTTLE; Type 0: Not a Combination Product07/27/201509/01/2021
3NDC:58602-132-16354 mL in 1 BOTTLE; Type 0: Not a Combination Product07/27/201509/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/27/201509/01/2021
Labeler - Aurohealth LLC (078728447)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurohealth LLC078728447MANUFACTURE(58602-132)

Revised: 11/2020
 
Aurohealth LLC