Tussin peak cold maximum strength cough plus chest congestion dm liquid

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:sodium8 mg
  • store at 20-25C (68-77F). 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

Ingredients and appearance - Product information

Tussin peak cold maximum strength cough plus chest congestion dm liquid- Dextromethorphan hbr, guaifenesin

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 58602-511
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Dextromethorphan hydrobromide ( UNII: 9D2RTI9KYH)( Dextromethorphan - UNII: 7355X3ROTS ) 20 mgin 10 mL
Guaifenesin ( UNII: 495W7451VQ)( Guaifenesin - UNII: 495W7451VQ ) 400 mgin 10 mL

Inactive Ingredients

Ingredient Name Code
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) Flavor VANILLA

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part341 USA

Labeler - Aurohealth LLC( 078728447)

Establishment

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

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
ColdMaximim 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

CherryFlavor
Non-Drowsy
4FL OZ (118 mL)