Cough Mucus Relief DM

Manufacturer
Strive Pharmaceuticals Inc.
Effective date
2020-10-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:31:32

Label at a glance#

ProductCough Mucus Relief DM
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 20mg

Guaifenesin 400mg

INACTIVE INGREDIENT SECTION

microcrystalline cellulose, sodium starch glycolate, talc, colloidal silicon dioxide,magnesium stearate, polyvinyl povidone, maltodextrin, stearic acid

* May contain hydroxypropyl methylcellulose, polyethylene glycol

DOSAGE & ADMINISTRATION SECTION

* take with a full glass of water

* swallow whole; do not crush, chew or dissolve

*do not take more than 6 tablets in 24 hours

adults and children 12 years of age and over1 tablet every 4 hours
children under 12 years of ageDo not use

INDICATIONS & USAGE SECTION

* temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold

* helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

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 you have

* persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis,or emphysema

* cough accompanied by too much phlegm (mucus)

When using this product do not use more than directed

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with 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 accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

OTC - PURPOSE SECTION

Cough Suppressant

Expectorant

OTHER SAFETY INFORMATION

* store at room temperature 25°C (77°F) ; excursions permitted between 15°C - 30°C (59°F - 86°F)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

101101CT10141CT10141

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1147685dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral TabletPSN4
1147685dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral TabletSCD4
1147685guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral TabletSY4

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
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70692-101-242022-01-28C16284748780-1d6a99b39-9691-a426-e053-dadaa90af4c2Dextromethorphan HBr 20mg and Guaifenesin 400mg
70692-101-412022-01-28C16284748780-1d6a99b39-9691-a426-e053-dadaa90af4c2Dextromethorphan HBr 20mg and Guaifenesin 400mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70692-101-24Cough Mucus Relief DM24 in 1 BOTTLETABLET244
70692-101-41Cough Mucus Relief DM4 in 1 PACKAGETABLET44

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70692-101COUGH MUCUS RELIEF DM (DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET [STRIVE PHARMACEUTICALS INC.]4Legacy NDC, 2 package rows20201014_6878aed8-df32-19f1-e053-2991aa0a614e.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70692-10170692-101-24, 70692-101-41

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
b193b6ae-555b-7d3e-e053-2a95a90a68146878aed8-df32-19f1-e053-2991aa0a614e2020-10-13WarningsExact identifier
spl id: b193b6ae-555b-7d3e-e053-2a95a90a6814
spl set id: 6878aed8-df32-19f1-e053-2991aa0a614e

Reported adverse events (FAERS/openFDA)#

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