AUROTUSSIN MAXIMUM STRENGTH DAYTIME AND NIGHTTIME COUGH RELIEF- dextromethorphan hbr, guaifenesin, dextromethorphan hbr, doxylamine succinate 
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 - 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 8 FL OZ (236 mL Bottle)

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)

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 - 4 FL OZ (118 mL Bottle)

AUROTUSSIN MAXIMUM STRENGTH DAYTIME AND NIGHTTIME COUGH RELIEF 
dextromethorphan hbr, guaifenesin, dextromethorphan hbr, doxylamine succinate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-160
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-160-371 in 1 CARTON; Type 0: Not a Combination Product05/27/201603/01/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 118 mL
Part 21 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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorRED (a red colored liquid) Score    
ShapeSize
FlavorCHERRY, VANILLAImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-116-241 in 1 CARTON
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 FINALpart34105/27/201603/01/2020
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 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, UNSPECIFIED FORM (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 CARTON
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 FINALpart34105/27/201603/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/27/201603/01/2020
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurohealth LLC078728447MANUFACTURE(58602-160)

Revised: 12/2020
 
Aurohealth LLC