Mucus Relief DM

Manufacturer
Strategic Sourcing Services LLC
Effective date
2023-04-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:54:40

Label at a glance#

ProductMucus Relief DM
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
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 or 2 tablet every 12 hours; not more than 4 tablets in 24 hours children under 12 years of age: do not use 

Label contents#

Full prescribing information#

Active ingredients (in each extended-release tablet)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 30 mg

Guaifenesin 600 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 or 2 tablet every 12 hours; not more than 4 tablets in 24 hours
  • children under 12 years of age: do not use 

Other information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-833-358-6431 Monday to Friday 9:00am to 7:00pm EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO MUCINEX® DM ACTIVE INGREDIENTS*

Mucus Relief DM

Guaifenesin 600 mg 

Dextromethorphan HBr 30 mg

EXPECTORANT

COUGH SUPPRESSANT

12-Hour Relief OF:

  • Controls cough
  • Thins & loosen mucus

EXTENDED-RELEASE TABLETS

*This product is not manufactured or distributed Reckitt Benckiser LLC, distributor of 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 McKesson Corp.,

via Strategic Sourcing Services LLC,

Memphis, TN 38141

wwwfosterandthrive.com

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FOSTER & THRIVE Mucus Relief DM
FOSTER & THRIVE Mucus Relief DM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSN1
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCD1
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
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
70677-1050-1Mucus Relief DM20 in 1 CARTONTABLET, EXTENDED RELEASE201
70677-1050-1Mucus Relief DM1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1050MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET, EXTENDED RELEASE [STRATEGIC SOURCING SERVICES LLC]1Current NDC, 2 package rows20230411_af359aca-ec58-47cb-843a-2def1a09a09a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1050-1EA - Each70677-10509d71e655-e849-4f37-8378-1afdf2e770c112023-09-05

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
70677-105070677-1050-1
65162-038

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRAmneal Pharmaceuticals LLC5760a828-1c28-4272-a7b7-ac98466aa2942024-10-25WarningsExact identifier
ndc (product): 65162-038
Mucus Relief DMGUAIFENESIN, DEXTROMETHORPHAN HBRStrategic Sourcing Services LLCaf359aca-ec58-47cb-843a-2def1a09a09a2023-04-10WarningsExact identifier
ndc (package): 70677-1050-1
ndc (product): 70677-1050
ndc11 (package): 70677105001
spl id: a45e0443-d2dc-4262-9741-e4cd99d915d3
spl set id: af359aca-ec58-47cb-843a-2def1a09a09a

Reported adverse events (FAERS/openFDA)#

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