FDA.reportPublic FDA data

Healthy Accents Tussin DM

Manufacturer
DZA Brands LLC
Effective date
2016-08-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:24:30

Label at a glance#

ProductHealthy Accents Tussin DM cough and chest congestion
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure13 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

• shake well before using • do not take more than 6 doses 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 7 mg • store at 20-25 ° C (68-77 ° F). Do not refrigerate.

Label contents#

Full prescribing information#

Active ingredients (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 400 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 for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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

  • shake well before using
  • do not take more than 6 doses 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

STORAGE AND HANDLING SECTION

  • each 10 mL contains: sodium 7 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, D&C red no. 33, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, menthol, microcrystalline cellulose and carboxymethylcellulose sodium, polyethylene glycol, povidone, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1-866-322-2439

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PEAK COLD

maximum strength

adult

tussin

DM

cough & chest congestion

cough suppressant

(dextromethorphan HBr)

expectorant (guaifenesin)

non-drowsy

for ages 12 & over

relieves:

cough

mucus

Compare to Robitussin® Maximum Strength Cough + Chest Congestion DM active ingredients

NO GLUTEN

8 FL OZ (237 mL)

alcohol free

Tussin DM Carton Image 1
Tussin DM Carton Image 1
Tussin DM Carton Image 2
Tussin DM Carton Image 2

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55316-55355316-553-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOLS3WJQ0SDW1AIACT
POVIDONESFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT
XANTHAN GUMTTV12P4NEEIACT

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
ae009809-7287-4754-8c9e-0df787eb7e4fc7bb0c27-6f18-4e55-b66b-5afc4ae3ec5f2019-11-18WarningsExact identifier
spl set id: c7bb0c27-6f18-4e55-b66b-5afc4ae3ec5f

Reported adverse events (FAERS/openFDA)#

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