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
Tussin Peak Cold Maximum Strength Cough plus Chest Congestion DM
- Manufacturer
- Aurohealth LLC
- Effective date
- 2019-11-28
- Label type
- Human OTC Drug Label
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:56:31
Label at a glance#
ProductTussin Peak Cold Maximum Strength Cough plus Chest Congestion DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure14 sections
Dosage and administration
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
Storage and handling
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
Contacts and useful links#
Label contents#
Full prescribing information#
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
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 - 8 FL OZ (237 mL Container Label)
NDC 58602-511-20
PrimaryHealth
COMPARE TO Adult Robitussin®
Peak Cold Maximim Strength Cough +
Chest Congestion DM active ingredients*
ADULT
Tussin
PEAK COLD
Maximum Strengh
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
MAX
For Ages 12 & Over
Cherry Flavor
Non-Drowsy
8 FL OZ (237 mL)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 FL OZ (237 mL Container Carton Label)
NDC 58602-511-20
PrimaryHealth
COMPARE TO Adult Robitussin®
Peak Cold Maximim Strengh Cough +
Chest Congestion DM active ingredients*
ADULT
Tussin
PEAK COLD
MAXIMUM STRENGTH
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
MAX
For Ages 12 & Over
Cherry Flavor
Non-Drowsy
8 FL OZ (237 mL)
Products#
Every source-derived product name is available through these pages.
- Tussin Peak Cold Maximum Strength Cough plus Chest Congestion DM
- Dextromethorphan HBr, Guaifenesin
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- GUAIFENESIN
- ANHYDROUS CITRIC ACID
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
- D&C RED NO. 33
- FD&C RED NO. 40
- CHERRY
- VANILLA
- GLYCERIN
- HIGH FRUCTOSE CORN SYRUP
- LEVOMENTHOL
- MICROCRYSTALLINE CELLULOSE 101
- POLYETHYLENE GLYCOL 400
- POVIDONE K30
- PROPYLENE GLYCOL
- WATER
- SODIUM BENZOATE
- SORBITOL
- SUCRALOSE
- XANTHAN GUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58602-511 | 58602-511-20 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 064f3c2a-c942-4e25-bb60-56c9c4b20f8e | 53a66dc7-2448-4796-bd66-fbfc1e9d693f | 2020-12-13 | Warnings | 53a66dc7-2448-4796-bd66-fbfc1e9d693f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.