FDA.reportPublic FDA data

Mucinex D

Manufacturer
REMEDYREPACK INC.
Effective date
2023-08-08
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 21:27:32

Label at a glance#

ProductMucinex D
Active ingredientGUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE
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 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)Purposes
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 homopolymer type B; FD&C yellow #6 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

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Mucinex D

GENERIC: Guaifenesin and Pseudoephedrine Hydrochloride

DOSAGE: TABLET, EXTENDED RELEASE

ADMINSTRATION: ORAL

NDC: 70518-0523-0

COLOR: orange

SHAPE: OVAL

SCORE: No score

SIZE: 16 mm

IMPRINT: Mucinex;600

PACKAGING: 18 in 1 BLISTER PACK

OUTER PACKAGING: 1 in 1 CARTON

ACTIVE INGREDIENT(S):

  • Pseudoephedrine Hydrochloride 60mg in 1
  • Guaifenesin 600mg in 1

INACTIVE INGREDIENT(S):

  • carbomer homopolymer type B (allyl pentaerythritol crosslinked)
  • FD&C yellow NO. 6
  • aluminum oxide
  • HYPROMELLOSE, UNSPECIFIED
  • magnesium stearate
  • MICROCRYSTALLINE CELLULOSE

MM1MM1

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
63824-057-36EA - Each63824-0571429e946-65a4-4011-8ae9-3c4ba733909d12012-07-24

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
70518-052370518-0523-0
63824-057

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
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
ALUMINUM OXIDELMI26O6933IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
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 44.

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 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-22c2088c7a36db…
2026-10-15 13:18:302026-09N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-22c2088c7a36db…
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…

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 (product): 63824-057
079c6cbc-e4c0-a1f0-e063-6294a90aba149cda526a-eb38-4b12-aa14-8e35ece123ff2023-10-13WarningsExact identifier
spl set id: 9cda526a-eb38-4b12-aa14-8e35ece123ff

Reported adverse events (FAERS/openFDA)#

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