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

Adult Tussin Maximum Strength Nighttime Cough DM by

Drug Labeling and Warnings

Adult Tussin Maximum Strength Nighttime Cough DM by is a Otc medication manufactured, distributed, or labeled by Aurohealth LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 - 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)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-512
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: 58602-512-24	1 in 1 CARTON	09/29/2018
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	09/29/2018

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(58602-512)