FDA.reportPublic FDA data

Dye Free Adult Cough Plus Chest Congestion DM

Manufacturer
CARDINAL HEALTH
Effective date
2024-04-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:05:08

Label at a glance#

ProductDye Free Adult Cough Plus Chest Congestion DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure8 sections

Storage and handling

Other information • each 20 ml contains: sodium 8 mg • store at room temperature. Do not refrigerate.

Label contents#

Full prescribing information#

Active ingredients (in each 20 ml)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 200 mg

Purposes

OTC - PURPOSE SECTION

Cough suppressant

Expectorant

INDICATIONS & USAGE SECTION

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 SECTION

Warnings

OTC - DO NOT USE SECTION

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.

OTC - ASK DOCTOR SECTION

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

OTC - STOP USE SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

DOSAGE & ADMINISTRATION SECTION

Directions

  • 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

20 ml every 4 hours

children under 12 years

do not use

STORAGE AND HANDLING SECTION

Other information

  • each 20 ml contains: sodium 8 mg
  • store at room temperature. Do not refrigerate.

INACTIVE INGREDIENT SECTION

Inactive ingredients

anhydrous citric acid, carboxymethyl cellulose sodium, disodium edetate, flavors, glycerin, menthol, potassium citrate, propylene glycol, purified water, sodium benzoate, sucralose, xanthan gum

OTC - QUESTIONS SECTION

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredients in Dye-Free Sugar-Free Adult Robitussin Cough + Chest Congestion DM*
NDC 70000-0651-1

DYE-FREE

Adult

Cough+Chest
Congestion DM

Dextromethorphan HBr (Cough Suppressant)
Guaifenesin (Expectorant)

  • Controls Cough
  • Relieves Chest Congestion
  • Thins & Loosens Mucus

Sugar-Free

No Added Alcohol
Specially
Formulated
for DIABETICS
Cherry Menthol Flavor

For Ages 12 & Over
8 FL OZ (237 ml)

*This product is not manufactured or distributed by GSK Consumer Healthcare, owner of the registered trademark DYE-FREE Sugar-Free Adult Robitussin Cough+chest Congestion DM.

Distributed by:

LEADER Dye-Free Adult Cough+Chest Congestion DM 237 ml
LEADER Dye-Free Adult Cough+Chest Congestion DM 237 ml

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-065170000-0651-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
POTASSIUM CITRATEEE90ONI6FFIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SUCRALOSE96K6UQ3ZD4IACT
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
227717ec-ab27-1a2d-e063-6394a90a538bdcb6bcd9-c0f9-429f-9ed6-0e282462b9ad2024-09-19WarningsExact identifier
spl set id: dcb6bcd9-c0f9-429f-9ed6-0e282462b9ad

Reported adverse events (FAERS/openFDA)#

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