FDA.reportPublic FDA data

Mucinex

Manufacturer
Rebel Distributors Corp
Effective date
2011-04-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:31:00

Label at a glance#

ProductMucinex
Active ingredientGuaifenesin
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

Dosage and administration

do not crush, chew, or break tablet take with a full glass of water this product can be administered without regard for the timing of meals adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours. children under 12 years of age: do not use

Storage and handling

tamper evident: do not use if carton is open or if printed seal on blister is broken or missing store between 20-25°C (68-77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each extended-release bi-layer tablet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 600 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

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

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use

  • for children under 12 years of age

OTC - ASK DOCTOR SECTION

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)

OTC - STOP USE SECTION

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 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 tablet
  • take with a full glass of water
  • this product can be administered without regard for the timing of meals
  • adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours.
  • children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

  • tamper evident: do not use if carton is open or if printed seal on blister is broken or missing
  • store between 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer 934P, NF; FD&C blue #1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

SPL UNCLASSIFIED SECTION

Distributed by:
Reckitt Benckiser Inc.
Parsippany, NJ 07054-0224
©RBI 2009

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

PRINCIPAL DISPLAY PANEL - 600 mg Tablet Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mucinex EXP 600mgMucinex EXP 600mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN2
891301Mucinex Expectorant 600 MG 12HR Extended Release Oral TabletPSN2
89130112 HR guaifenesin 600 MG Extended Release Oral Tablet [Mucinex]SBD2
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD2
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY2
891301Mucinex 600 MG 12 HR Extended Release Oral TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-870-202019-09-24C16284748780-1934fe258-49c8-48b1-e053-8cdaa90a720aMucinex ®
21695-870-402019-09-24C16284748780-1934fe258-49c8-48b1-e053-8cdaa90a720aMucinex ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-870-20Mucinex10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE102
21695-870-20Mucinex2 in 1 CARTONTABLET, EXTENDED RELEASE22
21695-870-40Mucinex4 in 1 CARTONTABLET, EXTENDED RELEASE42
21695-870-40Mucinex10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-870MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]2Legacy NDC, 4 package rows20120223_e4ac51f1-9b5e-49ad-ac79-dde6e91b65e9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-870-20EA - Each21695-870a71cf3dd-6df0-45d9-9087-030cea7c541912012-07-24
21695-870-40EA - Each21695-870c788183e-cae4-43ca-b5b2-eb3c3e32401512012-07-24
63824-008-10EA - Each63824-0088a8fe46e-a8dd-4e88-a43a-b5cb234a182912012-07-24
63824-008-15EA - Each63824-008825a9c5e-a011-46d2-99d6-82b24621a35c12012-07-24
63824-008-24EA - Each63824-00872c29d28-4125-47bc-a9ec-025f76ffd69612021-04-08
63824-008-27EA - Each63824-008a3f2c15b-af9a-4992-9bc6-7c96ac06d52812012-07-24
63824-008-32EA - Each63824-008c12fa728-b6ba-4d9e-bf3c-e1fc7a5bc37c12012-07-24
63824-008-34EA - Each63824-0085a5a0482-291d-411b-bb0d-c85d2367ceaf12012-07-24
63824-008-36EA - Each63824-00825620952-bffc-449b-b2e6-ae1d2775da2912015-08-04
63824-008-50EA - Each63824-008e12bb389-684d-4137-99d0-3e29d2382e4012012-07-24
63824-008-61EA - Each63824-008ce5a1472-3ac2-498b-9b40-7c3466571b8212012-07-24
63824-008-62EA - Each63824-0083b8a427e-50ac-43b6-8ba5-13928b4404c312012-07-24
63824-008-69EA - Each63824-008d3a2bb0a-6b5f-41cd-9303-be145966acbe12012-07-24
63824-008-80EA - Each63824-00804e1bccb-c1ee-4f6c-aa00-e5c02d9d507312021-04-08
63824-008-86EA - Each63824-0087dec4237-179d-4a1b-a329-3781acde223812016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
GuaifenesinACTIVE INGREDIENT495W7451VQ2
GuaifenesinACTIVE MOIETY495W7451VQ2
CARBOMER 934INACTIVE INGREDIENTZ135WT92082
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I302
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A22

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21695-87021695-870-20, 21695-870-40
63824-008

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
Guaifenesin495W7451VQACTIB
CARBOMER 934Z135WT9208IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 5 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CARBOMER 934CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208TABLET, EXTENDED RELEASE / ORAL90 mgExact identifier — unii+route+dosage form
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii+route+dosage form
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, EXTENDED RELEASE / ORAL1472 mgExact identifier — unii+route+dosage form
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, EXTENDED RELEASE / ORAL5119 mgExact identifier — unii+route+dosage form
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, EXTENDED RELEASE / ORAL173 mgExact identifier — unii+route+dosage form

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
N021282-001MUCINEXGUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-12
N021282-002MUCINEXGUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-18

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 22:38:342026-08N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-1284e616aacf4f…
2026-09-14 22:38:342026-08N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-1884e616aacf4f…
2026-08-18 06:07:402026-07N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-12caaa826d4ba7…
2026-08-18 06:07:402026-07N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-12d06236e962d9…
2024-10-29 15:01 UTC2024-10N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-1874a2ff9319b5…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021282-00163722522020-04-28U-48974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021282-00169558212020-04-28U-489Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021282-00178380322020-04-28Drug product2010-12-2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021282-00263722522020-04-28U-48974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021282-00269558212020-04-28U-489Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021282-00278380322020-04-28Drug product74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N021282-00163722522020-04-28U-4898869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021282-00169558212020-04-28U-489Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021282-00178380322020-04-28Drug product2010-12-218869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021282-00263722522020-04-28U-4898869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021282-00269558212020-04-28U-489Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021282-00278380322020-04-28Drug product8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021282-00163722522020-04-28U-489c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021282-00169558212020-04-28U-489Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021282-00178380322020-04-28Drug product2010-12-21c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021282-00263722522020-04-28U-489c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021282-00269558212020-04-28U-489Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021282-00278380322020-04-28Drug productc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021282-00163722522020-04-28U-4893f01610625f2…
2019-12-14 00:12 UTC2019-12N021282-00169558212020-04-28U-489Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021282-00178380322020-04-28Drug product2010-12-213f01610625f2…
2019-12-14 00:12 UTC2019-12N021282-00263722522020-04-28U-4893f01610625f2…
2019-12-14 00:12 UTC2019-12N021282-00269558212020-04-28U-489Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021282-00278380322020-04-28Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N021282-00163722522020-04-28U-489b00525d2431f…
2019-09-15 20:21 UTC2019-09N021282-00169558212020-04-28U-489Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021282-00178380322020-04-28Drug product2010-12-21b00525d2431f…
2019-09-15 20:21 UTC2019-09N021282-00263722522020-04-28U-489b00525d2431f…
2019-09-15 20:21 UTC2019-09N021282-00269558212020-04-28U-489Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021282-00278380322020-04-28Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N021282-00163722522020-04-28U-489ea99ee380514…
2019-07-19 19:46 UTC2019-07N021282-00169558212020-04-28U-489Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021282-00178380322020-04-28Drug product2010-12-21ea99ee380514…
2019-07-19 19:46 UTC2019-07N021282-00263722522020-04-28U-489ea99ee380514…
2019-07-19 19:46 UTC2019-07N021282-00269558212020-04-28U-489Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021282-00278380322020-04-28Drug 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
MucinexGUAIFENESINReckitt Benckiser LLCdd379cdd-90ab-42e0-ad89-f50d3220f6112026-05-27WarningsExact identifier
ndc (product): 63824-008
fbc8717c-8980-4cab-9518-84eb732df072e4ac51f1-9b5e-49ad-ac79-dde6e91b65e92011-04-13WarningsExact identifier
spl id: fbc8717c-8980-4cab-9518-84eb732df072
spl set id: e4ac51f1-9b5e-49ad-ac79-dde6e91b65e9

Reported adverse events (FAERS/openFDA)#

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