FDA.reportPublic FDA data

Mucinex®DM

Manufacturer
Select Consumer Group
Effective date
2026-08-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-09-02 00:03:24

Label at a glance#

ProductMucinex DM
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure10 sections

Indications and uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep

Dosage and administration

do not crush, chew, or break extended-release tablet take with a full glass of water this product can be administered without regard for timing of meals adults and children 12 years and older: 1 or 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours children under 12 years of age: do not use

Storage and handling

store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each extended-release tablet)
Dextromethorphan HBr 30 mg
Guaifenesin 600 mg

OTC - PURPOSE SECTION

Active ingredients (in each extended-release tablet)Purposes
Dextromethorphan HBr 30 mgCough suppressant
Guaifenesin 600 mgExpectorant

Uses

INDICATIONS & USAGE SECTION

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help you get to sleep

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • for children under 12 years of age
  • 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

  • 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

OTC - WHEN USING SECTION

  • do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not crush, chew, or break extended-release tablet
  • take with a full glass of water
  • this product can be administered without regard for timing of meals
  • adults and children 12 years and older: 1 or 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours
  • children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer homopolymer type B; D&C yellow no. 10 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Questions?

OTC - QUESTIONS SECTION

1-866-MUCINEX (1-866-682-4639)

SPL UNCLASSIFIED SECTION

Dist. by: RB Health (US)
Parsippany, NJ 07054-0224

Made in England

PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63824-056-32

Mucinex®DM

600 mg guaifenesin & 30 mg dextromethorphan HBr
extended-release tablets

EXPECTORANT & COUGH SUPPRESSANT

12
HOUR ®

  • Controls Cough
  • Thins and Loosens Mucus
  • Immediate and Extended Release

20
EXTENDED-RELEASE TABLETS

full carton labelfull carton label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codewww.mucinex.com/pages/product-faqs63824-056 full carton label.jpg

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-056-11EA - Each63824-056655a18b2-6c33-406d-8991-df75dc62ce5012021-04-08
63824-056-32EA - Each63824-056618c9634-633e-4967-9062-e99d6d608aab12012-07-24
63824-056-34EA - Each63824-05680569af0-2f07-4c5f-afdd-03fa8c52725612012-07-24
63824-056-36EA - Each63824-0566e774f37-0653-4855-a554-aa950008a74e12015-08-04
63824-056-50EA - Each63824-056219793fd-10e1-4304-a49e-36b3fcd093cc12021-07-15
63824-056-69EA - Each63824-056dea4a8a7-ef9d-4fd9-878a-24860e0261d112012-07-24
63824-056-80EA - Each63824-056022c0ea0-bcea-44b4-8022-eba46b028ae212024-08-12
63824-056-89EA - Each63824-0561858b821-0392-4596-912a-f59857e7c3a812019-11-12

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85237-165085237-1650-1, 85237-1650-3
63824-056

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
ALUMINUM OXIDELMI26O6933IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-12-28full-release2026-06-01 01:28:52

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021620-001MUCINEX DMDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-29
N021620-002MUCINEX DMDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-29

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-2984e616aacf4f…
2026-09-14 22:38:342026-08N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-2984e616aacf4f…
2026-08-18 06:07:402026-07N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-2974a2ff9319b5…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021620-00163722522020-04-28Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021620-00169558212020-04-28U-685Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021620-00178380322020-04-28Drug product2010-12-2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021620-00263722522020-04-28Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021620-00269558212020-04-28U-685Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021620-00278380322020-04-28Drug product74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N021620-00163722522020-04-28Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021620-00169558212020-04-28U-685Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021620-00178380322020-04-28Drug product2010-12-218869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021620-00263722522020-04-28Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021620-00269558212020-04-28U-685Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021620-00278380322020-04-28Drug product8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021620-00163722522020-04-28Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021620-00169558212020-04-28U-685Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021620-00178380322020-04-28Drug product2010-12-21c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021620-00263722522020-04-28Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021620-00269558212020-04-28U-685Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021620-00278380322020-04-28Drug productc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021620-00163722522020-04-28Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021620-00169558212020-04-28U-685Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021620-00178380322020-04-28Drug product2010-12-213f01610625f2…
2019-12-14 00:12 UTC2019-12N021620-00263722522020-04-28Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021620-00269558212020-04-28U-685Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021620-00278380322020-04-28Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N021620-00163722522020-04-28Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021620-00169558212020-04-28U-685Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021620-00178380322020-04-28Drug product2010-12-21b00525d2431f…
2019-09-15 20:21 UTC2019-09N021620-00263722522020-04-28Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021620-00269558212020-04-28U-685Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021620-00278380322020-04-28Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N021620-00163722522020-04-28Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021620-00169558212020-04-28U-685Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021620-00178380322020-04-28Drug product2010-12-21ea99ee380514…
2019-07-19 19:46 UTC2019-07N021620-00263722522020-04-28Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021620-00269558212020-04-28U-685Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021620-00278380322020-04-28Drug productea99ee380514…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex DMGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDESelect Consumer Group3c9c8fb0-8a00-4b0f-e063-6394a90af6322026-08-30WarningsExact identifier
ndc (package): 85237-1650-3
ndc (package): 85237-1650-1
ndc (product): 85237-1650
ndc11 (package): 85237165001
ndc11 (package): 85237165003
spl id: 5a4d33e6-8f71-c819-e063-6394a90ab01c
spl set id: 3c9c8fb0-8a00-4b0f-e063-6394a90af632
Mucinex DMGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC70987d06-d206-445f-bd0d-5e1345b8465c2026-06-15WarningsExact identifier
ndc (product): 63824-056

Reported adverse events (FAERS/openFDA)#

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