Mucus Relief DM Extended Release Caplets

Manufacturer
QUALITY CHOICE (Chain Drug Marketing Association)
Effective date
2023-05-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:54:51

Label at a glance#

ProductMucus Relief DM Extended Release Caplets
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
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 tablet take with a full glass of water  this product can be administered without regards for timing of meals adults and children 12 years of age and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours children under 12 years of age: do not use 

Storage and handling

store between 20º to 25ºC (68º to 77ºF)

Label contents#

Full prescribing information#

Active ingredients (in each extended-release tablet)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 60 mg

Guaifenesin 1200 mg

Purpose

OTC - PURPOSE SECTION

Cough Suppressant

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
  • 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 under12 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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

  • store between 20º to 25ºC (68º to 77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer, colloidal silicon dioxide, D&Cyellow #10 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, talc

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-248-449-9300 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare to the Active Ingredients in Maximum Strength Mucinex® DM

Maximum strength

Mucus Relief DM

Guaifenesin 1200 mg

& Dextromethorphan HBr 60 mg

Extended-Release Tablets

Expectorant & Cough Suppressant

12 Hour Relief

  • Controls Cough
  • Thins and Loosens Mucus

Extended-Release Tablets

*This product is not manufactured or distributed Reckitt Benckiser LLC, distributor  of Maximum Strength Mucinex® DM.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by C.D.M.A., Inc.©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QUALITY CHOICE Maximum Strength Mucus Relief DM
QUALITY CHOICE Maximum Strength Mucus Relief DM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSN3
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCD3
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY3

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-870-14Mucus Relief DM Extended Release Caplets1 in 1 BLISTER PACKTABLET13
63868-870-14Mucus Relief DM Extended Release Caplets14 in 1 CARTONTABLET143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-870MUCUS RELIEF DM EXTENDED RELEASE CAPLETS (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3Current NDC, Legacy NDC, 2 package rows20230504_ee34af0f-61ba-49fa-81e0-20da4c582368.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-870-14EA - Each63868-870294772a8-d8c4-447d-8f3d-4b6b968c074212022-10-06

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-87063868-870-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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
A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-01
A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-01

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 22:38:342026-08A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-0184e616aacf4f…
2026-09-14 22:38:342026-08A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-0184e616aacf4f…
2026-08-18 06:07:402026-07A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-01caaa826d4ba7…
2026-08-18 06:07:402026-07A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-018072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-015c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-015d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-014b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209692-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-11-0174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209692-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-11-0174a2ff9319b5…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucus Relief DM Extended Release CapletsGUAIFENESIN, DEXTROMETHORPHAN HBRQUALITY CHOICE (Chain Drug Marketing Association)ee34af0f-61ba-49fa-81e0-20da4c5823682023-05-03WarningsExact identifier
ndc (package): 63868-870-14
ndc (product): 63868-870
ndc11 (package): 63868087014
spl id: 63708ea4-8e73-41a7-9bb7-184d112f86be
spl set id: ee34af0f-61ba-49fa-81e0-20da4c582368

Reported adverse events (FAERS/openFDA)#

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