Tussin Peak Cold Cough plus Chest Congestion DM

Manufacturer
Aurohealth LLC
Effective date
2020-11-27
Label type
Human OTC Drug Label
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:04:22

Label at a glance#

ProductTussin Peak Cold Cough plus Chest Congestion DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure14 sections

Indications and 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

Dosage and administration

do not take more than 6 doses (12 tsp) in any 24-hour period keep dosing cup with product measure only with dosing cup provided this adult product is not intended for use in children under 12 years of age mL = milliliter Age Dose adults and children 12 years and over 10 mL every 4 hours children under 12 years do not use

Storage and handling

each 10 mL contains: sodium 6 mg store at 20-25°C (68-77°F). Do not refrigerate. see bottom panel for lot number and expiration date

Label contents#

Full prescribing information#

Active ingredients (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, USP 20 mg
Guaifenesin, USP 200 mg

Purposes

OTC - PURPOSE SECTION

Cough suppressant
Expectorant

Uses

INDICATIONS & USAGE SECTION

  • 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

Do not use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

  • 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

OTC - STOP USE SECTION

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 6 doses (12 tsp) in any 24-hour period
  • keep dosing cup with product
  • measure only with dosing cup provided
  • this adult product is not intended for use in children under 12 years of age
  • mL = milliliter

Age
Dose
adults and children 12 years
and over
10 mL
every 4 hours
children under 12 years
do not use

Other information

STORAGE AND HANDLING SECTION

  • each 10 mL contains: sodium 6 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.
  • see bottom panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, FD&C red #40, flavors, glycerin, high fructose corn syrup, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, xanthan gum.

Questions or Comments

OTC - QUESTIONS SECTION

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)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58602-521-20

PrimaryHealth

COMPARE TO Adult Robitussin®
Peak Cold 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)
200 mg - Guaifenesin, USP (Expectorant)

Relieves:

• Cough
• Mucus

DM

For Ages 12 & Over

Pineapple Flavor
Non-Drowsy
8 FL OZ (236 mL)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 FL OZ (236 mL Bottle)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 FL OZ (236 mL Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 FL OZ (236 mL Container Carton Label)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58602-521-20

PrimaryHealth

COMPARE TO Adult Robitussin
®
Peak Cold 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)
200 mg - Guaifenesin, USP (Expectorant)

Relieves:

• Cough
• Mucus

DM

For Ages 12 & Over

Pineapple Flavor                              
Non-Drowsy
8 FL OZ (236 mL)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 FL OZ (236 mL Container Carton Label)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 FL OZ (236 mL Container Carton Label)

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58602-52158602-521-20

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c2f9ea41-c7a3-455e-8d94-abdd22aa5238e3093c44-ef78-44cd-8fe5-c425cf976f1c2020-11-27WarningsExact identifier
spl id: c2f9ea41-c7a3-455e-8d94-abdd22aa5238
spl set id: e3093c44-ef78-44cd-8fe5-c425cf976f1c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.