First Aid Direct Cough Relief DM

Manufacturer
Cintas Corporation | ULTRAtab Laboratories, Inc.
Effective date
2022-08-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:50:22

Label at a glance#

ProductFirst Aid Direct Cough Relief DM
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure12 sections

Indications and uses

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

Dosage and administration

do not take more than 6 doses in 24 hours, or as directed by a doctor. adults and children 12 years and over, take one premeasured single dose dispenser (2 teaspoons) every 4 hours children 6-11 years, measure out and take only 1 teaspoon every 4 hours children 2 to 5 years, measure out and take only 1/2 teaspoon every 4 hours children under 2 years, consult your doctor

Label contents#

Full prescribing information#

Active ingredients (each 5mL/1 teaspoon)

OTC - ACTIVE INGREDIENT SECTION

  • Dextromethorphan HBr 10mg
  • Guaifenesin 100 mg

Purposes

OTC - PURPOSE SECTION

cough suppressant

expectorant

Uses

INDICATIONS & USAGE SECTION

temporarily:

  • relieves coughing due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

WARNINGS SECTION

Do not use

this product for persistent or chronic cough such as occurs with smoking, asthma, emphysema or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. 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 are uncertain whether your prescription drug contains an MAOI, consult a health professional before taking this product.

Stop use and ask doctor if

OTC - STOP USE SECTION

  • cough persists for more than 1 week, tends to recur 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.

Directions

DOSAGE & ADMINISTRATION SECTION

do not take more than 6 doses in 24 hours, or as directed by a doctor.

  • adults and children 12 years and over, take one premeasured single dose dispenser (2 teaspoons) every 4 hours
  • children 6-11 years, measure out and take only 1 teaspoon every 4 hours
  • children 2 to 5 years, measure out and take only 1/2 teaspoon every 4 hours
  • children under 2 years, consult your doctor

Other information

OTHER SAFETY INFORMATION

  • do not use if dispenser is torn, cut or opened
  • store at room temperature
  • avoid excessive heat and humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, FD&C red 40, flavor, glycerin, methyl paraben, propylene glycol, propyl paraben, purified water, sodium citrate, sucralose

Questions?

OTC - QUESTIONS SECTION

1-800-327-2704

Package Label Principal Display Panel Single Dose Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BEND HERE 

AND TEAR

Cough Relief DM

COUGH SUPPRESSANT EXPECTORANT

1/3 FL OZ (10 mL)

(2 Teaspoons)

pouchpouch

pouchpouch

Package Label Principal Display Panel Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cough Relief DM

COUGH SUPPRESSANT

EXPECTORANT

LIQUID COUGH FORMULA

  • CONTROLS COUGHS
  • LOOSENS and RELIEVES CHEST CONGESTIONS
  • ALCOHOL-FREE
  • NON DROWSY FORMULA

6-10mL Doses per Box

boxbox

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN2
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD2
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY2
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY2
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY2

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
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42961-121-022023-07-28C16284748780-10191ceaa-64f6-198a-e063-dbdaa90aec3eFirst Aid Direct Cough Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42961-121-01First Aid Direct Cough Relief DM10 mL in 1 DOSE PACKSYRUP102
42961-121-02First Aid Direct Cough Relief DM6 in 1 BOXSYRUP62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42961-121FIRST AID DIRECT COUGH RELIEF DM (GUAIFENESIN DEXTROMETHORPHAN HBR) SYRUP [CINTAS CORPORATION]2Legacy NDC, 2 package rows20220811_d214b3e2-a626-42e9-a587-727b9017d62e.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42961-12142961-121-01, 42961-121-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
87824a21-c2c7-4af6-b55a-957676b01f06d214b3e2-a626-42e9-a587-727b9017d62e2022-08-10WarningsExact identifier
spl id: 87824a21-c2c7-4af6-b55a-957676b01f06
spl set id: d214b3e2-a626-42e9-a587-727b9017d62e

Reported adverse events (FAERS/openFDA)#

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