AUROQUIL COUGH NIGHTTIME COUGH RELIEF- dextromethorphan hbr and doxylamine succinate solution

AuroQuil Cough Nighttime Cough Relief by

Drug Labeling and Warnings

AuroQuil Cough Nighttime Cough Relief by is a Otc medication manufactured, distributed, or labeled by Aurohealth LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

PURPOSE

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 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 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)

                                                                       

INGREDIENTS AND APPEARANCE

AUROQUIL COUGH NIGHTTIME COUGH RELIEF 
dextromethorphan hbr and doxylamine succinate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-132
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	RED	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-132-20	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/27/2015
2	NDC: 58602-132-18	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/27/2015
3	NDC: 58602-132-16	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/27/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	07/27/2015

Labeler - Aurohealth LLC (078728447)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(58602-132)