Mucinex D

Manufacturer
Dispensing Solutions Inc.
Effective date
2010-03-02
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:08:04

Label at a glance#

ProductMucinex D
Active ingredientGUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE
Label structure9 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 nasal congestion due to: common cold hay fever upper respiratory allergies temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage temporarily relieves sinus congestion and pressure

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 timing of meals adults and children 12 years and older: 2 tablets every 12 hours; not more than 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 at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each extended-release bi-layer tablet)Purpose
Guaifenesin 600 mgExpectorant
Pseudoephedrine HCl 60 mgNasal Decongestant

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 nasal congestion due to:
    • common cold
    • hay fever
    • upper respiratory allergies
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
  • temporarily relieves sinus congestion and pressure

Warnings

WARNINGS SECTION

OTC - DO NOT USE 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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by too much phlegm (mucus)

OTC - WHEN USING SECTION

When using this product

  • do not use more than directed

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • symptoms do not get better within 7 days, come back or occur with a 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 timing of meals
  • adults and children 12 years and older: 2 tablets every 12 hours; not more than 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 at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer 934P, NF; FD&C yellow #6 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

How Supplied

HOW SUPPLIED SECTION

Mucinex®D is supplied by Dispensing Solutions Inc. as follows:

NDCStrengthQuantity/FormColorSource NDC
68258-3035-1600 mg / 60 mg18 TabletsWHITE63824-057-18

This product was:

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

And Relabeled By:

Dispensing Solutions Inc.
3000 West Warner Ave
Santa Ana, CA 92704
United States

PRINCIPAL DISPLAY PANEL - 600 mg Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68258-3035-1

Mucinex®D

600 mg guaifenesin & 60 mg pseudoephedrine HCl
extended-release bi-layer tablets

EXPECTORANT & NASAL DECONGESTANT

12 HOUR

NEW LOOK-
SAME RELIEF

Thins And Loosens Mucus

Clears Nasal/Sinus Congestion

18 EXTENDED-RELEASE BI-LAYER TABLETS

Principal Display Panel
Principal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305603guaiFENesin 600 MG / pseudoephedrine HCl 60 MG 12HR Extended Release Oral TabletPSN1
130560312 HR guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG Extended Release Oral TabletSCD1
1305603guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG 12 HR Extended Release Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PSEUDOEPHEDRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68258-3035-12019-10-21C16284748780-1956f9ecf-bbce-621f-e053-dbdaa90a74adMucinex®D

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68258-3035-1Mucinex D9 in 1 BLISTER PACKTABLET, EXTENDED RELEASE91
68258-3035-1Mucinex D2 in 1 CARTONTABLET, EXTENDED RELEASE21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68258-3035MUCINEX D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS INC.]1Legacy NDC, 2 package rows20100303_98149172-3ec7-4212-9a37-5501bbfb5829.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-057-18EA - Each63824-0579f595d60-5dc2-4bdd-9cd6-2fa7809a206312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
GUAIFENESINACTIVE INGREDIENT495W7451VQ1
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8N1
GuaifenesinACTIVE MOIETY495W7451VQ1
PseudoephedrineACTIVE MOIETY7CUC9DDI9F1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68258-303568258-3035-1
63824-05763824-057-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
PSEUDOEPHEDRINE HYDROCHLORIDE6V9V2RYJ8NACTIB

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
N021585-001MUCINEX DGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-22
N021585-002MUCINEX DGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-22

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 22:38:342026-08N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-2284e616aacf4f…
2026-09-14 22:38:342026-08N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-2284e616aacf4f…
2026-08-18 06:07:402026-07N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-22caaa826d4ba7…
2026-08-18 06:07:402026-07N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-22d06236e962d9…
2024-10-29 15:01 UTC2024-10N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-2274a2ff9319b5…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021585-00163722522020-04-28Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021585-00169558212020-04-28U-686Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021585-00178380322020-04-28Drug product2010-12-2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021585-00263722522020-04-28Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021585-00269558212020-04-28U-686Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021585-00278380322020-04-28Drug product74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N021585-00163722522020-04-28Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021585-00169558212020-04-28U-686Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021585-00178380322020-04-28Drug product2010-12-218869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021585-00263722522020-04-28Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021585-00269558212020-04-28U-686Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021585-00278380322020-04-28Drug product8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021585-00163722522020-04-28Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021585-00169558212020-04-28U-686Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021585-00178380322020-04-28Drug product2010-12-21c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021585-00263722522020-04-28Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021585-00269558212020-04-28U-686Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021585-00278380322020-04-28Drug productc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021585-00163722522020-04-28Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021585-00169558212020-04-28U-686Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021585-00178380322020-04-28Drug product2010-12-213f01610625f2…
2019-12-14 00:12 UTC2019-12N021585-00263722522020-04-28Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021585-00269558212020-04-28U-686Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021585-00278380322020-04-28Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N021585-00163722522020-04-28Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021585-00169558212020-04-28U-686Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021585-00178380322020-04-28Drug product2010-12-21b00525d2431f…
2019-09-15 20:21 UTC2019-09N021585-00263722522020-04-28Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021585-00269558212020-04-28U-686Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021585-00278380322020-04-28Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N021585-00163722522020-04-28Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021585-00169558212020-04-28U-686Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021585-00178380322020-04-28Drug product2010-12-21ea99ee380514…
2019-07-19 19:46 UTC2019-07N021585-00263722522020-04-28Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021585-00269558212020-04-28U-686Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021585-00278380322020-04-28Drug 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 DGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEReckitt Benckiser LLCd5f046c0-66b9-4cdc-9a1e-8e2cb5ece84f2026-05-27WarningsExact identifier
ndc (package): 63824-057-18
ndc11 (package): 63824005718
f7d4a75c-bde1-4166-b6f8-70b8df2e7fe998149172-3ec7-4212-9a37-5501bbfb58292010-03-02WarningsExact identifier
spl id: f7d4a75c-bde1-4166-b6f8-70b8df2e7fe9
spl set id: 98149172-3ec7-4212-9a37-5501bbfb5829

Reported adverse events (FAERS/openFDA)#

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