FDA.reportPublic FDA data

Mucinex

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC
Effective date
2017-12-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:53:31

Label at a glance#

ProductMucinex
Active ingredientGuaifenesin
Label structure12 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

Do not use

OTC - DO NOT USE SECTION

  • for children under 12 years of age

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)

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 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 homopolymer type B; FD&C blue #1 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)

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224

Made in England

Repackaging Information

SPL UNCLASSIFIED SECTION

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count600 mg
6067544-149-53
12067544-149-70
18067544-149-80

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:
Aphena Pharma Solutions - TNAphena Pharma Solutions - TN
Cookeville, TN 38506

20171218DKJ

PRINCIPAL DISPLAY PANEL - 600mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 67544-149 Guaifenesin (Mucinex) ER 600mg - Rx Only
Bottle Label 600mgBottle Label 600mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN1
891301Mucinex Expectorant 600 MG 12HR Extended Release Oral TabletPSN1
89130112 HR guaifenesin 600 MG Extended Release Oral Tablet [Mucinex]SBD1
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD1
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY1
891301Mucinex 600 MG 12 HR Extended Release Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67544-149-53Mucinex60 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE601
67544-149-70Mucinex120 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1201
67544-149-80Mucinex180 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-149MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 3 package rows20171219_1c84bf00-ebaa-4e69-a2c6-716631d209d9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-149-53EA - Each67544-149bdf304dc-4df1-4041-9b4d-2511a206ee9e12018-01-12
67544-149-70EA - Each67544-14990be6829-a099-4054-8905-e945ed9d5e8e12018-01-12
67544-149-80EA - Each67544-149d2960c09-3376-4036-8a6a-bff56af7b1c412018-01-12
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

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67544-14967544-149-53, 67544-149-70, 67544-149-80
63824-008

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
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
ALUMINUM OXIDELMI26O6933IACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT

Source Document#

Source XML

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
MucinexGUAIFENESINAphena Pharma Solutions - Tennessee, LLC1c84bf00-ebaa-4e69-a2c6-716631d209d92017-12-18WarningsExact identifier
ndc (package): 67544-149-70
ndc (package): 67544-149-80
ndc (package): 67544-149-53
ndc (product): 67544-149
ndc11 (package): 67544014980
ndc11 (package): 67544014953
ndc11 (package): 67544014970
spl id: cc734890-e42c-454a-b771-3ecd169d161a
spl set id: 1c84bf00-ebaa-4e69-a2c6-716631d209d9

Reported adverse events (FAERS/openFDA)#

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