FDA.reportPublic FDA data

Cough Suppressant and Expectorant DM

Manufacturer
We Care Distributor Inc. | PURINE PHARMA LLC
Effective date
2016-08-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:46:41

Label at a glance#

ProductCough Suppressant and Expectorant DM
Active ingredientDextromethorphan Hydrobromide, GUAIFENESIN
Label structure12 sections

Indications and uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with cold. It helps helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Dosage and administration

Do not take more than 6 doses in a 24-hour period Repeat dose every 4 hours while symptoms last           AGE                                     DOSE adults and children 12 years of age and over               10 mL     children 6 years to under 12 years of age                    5 mL children 2 years to under 6 years of age                      2.5 mL children under under 2 years of age                      ask a...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 100 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant
Expectorant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves cough due to minor throat and bronchial irritation as may occur with cold. It helps helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

WARNINGS 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.

Ask a doctor before use if

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 accompanied by fever, rash, or persistant 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 the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Do not take more than 6 doses in a 24-hour period
  • Repeat dose every 4 hours while symptoms last

          AGE                                     DOSE

adults and children

12 years of age and over               10 mL    

children 6 years to

under 12 years of age                    5 mL

children 2 years to

under 6 years of age                      2.5 mL

children under

under 2 years of age                      ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • Store at 15-30°C (59-86°F)
  • Protect from freezing
  • Alcohol free
  • Protect from light
  • Each teaspoon 5mL contains: Sodium 3 mg

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, dextrose**, flavor, FD&C red #40, glucose, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium,
sodium benzoate

** contains one or more of these ingredients

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the Active Ingredients in Robitussin DM

Dextromethorphan HBr, 10 mg - guaifenesin, 100 mg

cough suppressant, expectorant

Non-Drowsy

Alcohol Free

Relieves- coughs, chest congestion and mucus

2 FL Oz (60 mL)

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN3
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD3
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY3
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY3
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70005-044-012020-01-31C16284748780-19d75b9d0-166f-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70005-044-01Cough Suppressant and Expectorant DM60 mL in 1 BOTTLE, PLASTICLIQUID603
70005-044-01Cough Suppressant and Expectorant DM1 in 1 CARTONLIQUID13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70005-044COUGH SUPPRESSANT AND EXPECTORANT DM (TUSSIN DM) LIQUID [WE CARE DISTRIBUTOR INC.]3Legacy NDC, 2 package rows20160802_2f8ed05f-7e52-4714-895a-912008d1b74f.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70005-04470005-044-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
Dextromethorphan Hydrobromide9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DEXTROSEIY9XDZ35W2IACT
GLYCERINPDC6A3C0OXIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
MENTHOLL7T10EIP3AIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
FD&C RED NO. 40WZB9127XOAIACT

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
dc3abb69-1bf1-4b3e-8160-05b0cf6192902f8ed05f-7e52-4714-895a-912008d1b74f2016-08-02WarningsExact identifier
spl id: dc3abb69-1bf1-4b3e-8160-05b0cf619290
spl set id: 2f8ed05f-7e52-4714-895a-912008d1b74f

Reported adverse events (FAERS/openFDA)#

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