ADULT TUSSIN 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

  • 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

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

  • 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

taking sedatives or tranquilizers

When using this product

  • 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

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

  • 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

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

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)

NDC 58602-512-24

PrimaryHealth

COMPARE TO Adult Robitussin®
Maximum Strength Nighttime
Cough DM Active Ingredients*

Adult
Tussin

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
For Ages 12 & Over
Max Strength
Nighttime Cough Control

DM
NIGHTTIME
MAX


Pineapple Flavor
4 FL OZ (118 mL)


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

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

NDC 58602-512-24

PrimaryHealth

COMPARE TO
Adult Robitussin®
Maximum Strength Nighttime
Cough DM Active Ingredients*

Adult
Tussin
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
For Ages 12 & Over
Max Strength
Nighttime Cough Control

DM
NIGHTTIME
MAX

Pineapple Flavor 
4 FL OZ (118mL)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL CONTAINER CARTON - 4 FL OZ (118 mL Bottle)

ADULT TUSSIN MAXIMUM STRENGTH NIGHTTIME COUGH DM 
dextromethorphan hbr, doxylamine succinate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-512
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:58602-512-241 in 1 CARTON09/29/201801/01/2020
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 FINALpart34109/29/201801/01/2020
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurohealth LLC078728447MANUFACTURE(58602-512)

Revised: 11/2020
 
Aurohealth LLC