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

Tussin Peak Cold Maximum Strength Cough plus Chest Congestion DM by

Drug Labeling and Warnings

Tussin Peak Cold Maximum Strength Cough plus Chest Congestion 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 20 mg
Guaifenesin, USP 400 mg

Purposes

Cough suppressant
Expectorant

Uses

• 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

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.

Ask a doctor before use if you have

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

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

• 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

Other information

• each 10 mL contains: sodium 8 mg
• store at 20-25°C (68-77°F). Do not refrigerate
• alcohol-free
• see bottom panel for lot number and expiration date

Inactive ingredients

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

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 Container Label)

NDC: 58602-511-24

PrimaryHealth

COMPARE TO Adult Robitussin® Peak
Cold Maximim Strength Cough + Chest
Congestion DM active ingredients*

ADULT

Tussin
PEAK COLD

Cough + Chest Congestion DM
Maximum Strengh

Each 10 mL dose of oral
solution contains:
20 mg - Dextromethorphan HBr, USP
(Cough Suppressant)
400 mg - Guaifenesin, USP
(Expectorant)

Relieves:

Cough Mucus

DM

For Ages 12 & Over 
Cherry Flavor
Non-Drowsy 
4 FL OZ (118 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ (118  mL Container Carton Label)

NDC: 58602-511-24

PrimaryHealth

COMPARE TO Adult Robitussin®Peak
Cold Maximim Strengh Cough + Chest
Congestion DM active ingredients*

ADULT

Tussin
PEAK COLD

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

For Ages 12 & Over

Cherry Flavor                              
Non-Drowsy
4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-511
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: 58602-511-24	1 in 1 CARTON	09/19/2018
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	09/19/2018

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(58602-511)