AUROTUSSIN MAXIMUM STRENGTH DAYTIME AND NIGHTTIME COUGH RELIEF- dextromethorphan hbr, guaifenesin, dextromethorphan hbr, doxylamine succinate kit

Aurotussin Maximum Strength Daytime and Nighttime Cough Relief by

Drug Labeling and Warnings

Aurotussin Maximum Strength Daytime and 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 - Day Time

Active ingredients (in each 10 mL)

Dextromethorphan HBr, USP 20 mg
Guaifenesin, USP 400 mg

Drug Facts - Night Time

Active ingredients (in each 10 mL)

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

Purposes - Day Time

Cough suppressant
Expectorant

Purposes - Night Time

Cough suppressant

Antihistamine

Uses - Day Time

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Uses - Night Time

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
• runny nose
• sneezing
• itchy, watery eyes
• itching of the nose or throat
• controls the impulse to cough to help you sleep

Warnings - Day Time

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.

Warnings - Night Time

Do not use

• to sedate a child or to make a child sleepy
• 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.

Ask a doctor before use if you have - Day Time

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

Ask a doctor before use if you have - Night Time

• trouble urinating due to an enlarged prostate gland
• glaucoma
• a cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema

Ask a doctor or pharmacist before use if you are - Night Time

taking sedatives or tranquilizers

When using this product - Night Time

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

Stop use and ask a doctor if - Day Time

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.

Stop use and ask a doctor if - Night Time

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, - Day Time

ask a health professional before use.

If pregnant or breast-feeding, - Night Time

ask a health professional before use.

Keep out of reach of children. - Day Time

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Keep out of reach of children. - Night Time

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions - Day Time

• shake well before using
• 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
• mL = milliliter
• this adult product is not intended for use in children under 12 years of age

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

Directions - Night Time

• measure only with dosing cup provided
• keep dosing cup with product
• mL = milliliter
• do not take more than 4 doses (8 tsp) in any 24-hour period
• this adult product is not intended for use in children under 12 years of age
• shake well before using

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

Other information - Day Time

• each 10 mL contains: sodium 8 mg
• store at 20-25°C (68-77°F). Do not refrigerate
• alcohol-free

Other information - Night Time

• each 10 mL contains: sodium 7 mg
• store at 20-25°C (68-77°F).
• alcohol-free

Inactive ingredients - Day Time

anhydrous citric acid, carboxymethylcellulose sodium, D&C red #33, FD&C red #40, flavors, glycerin, high fructose corn syrup, menthol, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Inactive ingredients - Night Time

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 8 FL OZ (236 mL Bottle)

AUROHEALTH

NDC: 58602-160-37

Compare to the active ingredients in
Adult

Robitussin®

Peak Cold
Maximum strength
Cough + Chest
Congestion DM*

ADULT

Aurotussin

PEAK COLD

MAXIMUM STRENGTH

Cough + Chest

Congestion DM

Each 10 mL dose of oral solution contains:

20 mg - Dextromethorphan HBr, USP (Cough Suppressant)

400 mg - Guaifenecin, USP (Expectorant)

Relieves:

• Cough
• Mucus

DM

MAX

Cherry Flavor

Non-Drowsy

4 FLOZ

(118 mL)

For Ages 12 & Over

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 (118 mL)

For Ages 12 & Over

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

AUROHEALTH

NDC: 58602-116-24

Compare to the active ingredients in
Adult Robitussin® Peak Cold
Maximum strength Cough + Chest
Congestion DM*

ADULT

Aurotussin

PEAK COLD

MAXIMUM STRENGTH

Cough + Chest Congestion DM

Each 10 mL dose of oral solution contains:

20 mg - Dextromethorphan HBr, USP (Cough Suppressant)

400 mg - Guaifenesin, USP (Expectorant)

Relieves:

• Cough
• Mucus

DM

MAX

Cherry Flavor

Non-Drowsy

4 FLOZ

(118 mL)

For Ages 12 & Over

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)

INGREDIENTS AND APPEARANCE

AUROTUSSIN MAXIMUM STRENGTH DAYTIME AND NIGHTTIME COUGH RELIEF 
dextromethorphan hbr, guaifenesin, dextromethorphan hbr, doxylamine succinate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-160

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-160-37	1 in 1 CARTON; Type 0: Not a Combination Product	05/27/2016

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	118 mL
Part 2	1 BOTTLE	118 mL

Part 1 of 2

AUROTUSSIN PEAK COLD MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM 
dextromethorphan hbr, guaifenesin liquid

Product Information
Item Code (Source)	NDC: 58602-116
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 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
CHERRY (UNII: BUC5I9595W)
VANILLA (UNII: Q74T35078H)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
LEVOMENTHOL (UNII: BZ1R15MTK7)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	RED (a red colored liquid)	Score
Shape		Size
Flavor	CHERRY, VANILLA	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-116-24	1 in 1 CARTON
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	05/27/2016

Part 2 of 2

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

Product Information
Item Code (Source)	NDC: 58602-159
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 10 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
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, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	RED (a clear red colored liquid)	Score
Shape		Size
Flavor	MENTHOL, ORANGE, PINEAPPLE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-159-24	1 in 1 CARTON
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	05/27/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	05/27/2016

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(58602-160)