FDA.reportPublic FDA data

Mucus Relief DM Extended Release Caplets

Manufacturer
ATLANTIC BIOLOGICALS CORP.
Effective date
2025-06-27
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:06:20

Label at a glance#

ProductMucus Relief DM Extended Release Caplets
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

Description

DESCRIPTION SECTION

Mucus Relief DM ER

Guaifenesin 600 mg (Expectorant)

Dextromethorphan HBr 30 mg (Cough Suppressant)

  • 12-hour Relief
  • Controls Cough
  • Thins & Loosens Mucus

Extended-release tablets, compared to the active ingredients in Mucinex DM.

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

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 condition.

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&Cyellow #10 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, talc

Questions or comments?

OTC - QUESTIONS SECTION

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

20101 NE 16TH PL

MIAMI, FL 33179

Call1-800-509-7592

Monday-Friday 9 AM - 5 PM EST

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSN5
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCD5
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSY5

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
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-1162-1Mucus Relief DM Extended Release Caplets1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE15
17856-1162-1Mucus Relief DM Extended Release Caplets100 in 1 CARTONTABLET, EXTENDED RELEASE1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1161-34EA - Each0536-11616d90fe03-3d29-4688-8aaf-81999e7a3ab512019-01-24
0536-1161-37EA - Each0536-1161099062de-6c77-43ba-a98a-b3253ae04f5912019-09-05

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
17856-116217856-1162-1
0536-1161

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT
CARBOMER 934Z135WT9208IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POVIDONEFZ989GH94EIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
TALC7SEV7J4R1UIACT
GUAIFENESIN495W7451VQACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB

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
Mucus Relief DM Extended Release CapletsGUAIFENESIN, DEXTROMETHORPHAN HBRRugby Laboratories69cd399a-0103-4543-bb06-c7cccffe9cc42026-02-10WarningsExact identifier
ndc (product): 0536-1161
Mucus Relief DM Extended Release CapletsGUAIFENESIN, DEXTROMETHORPHAN HBRATLANTIC BIOLOGICALS CORP.308f50dd-e8d6-0264-e063-6394a90afa682025-06-27WarningsExact identifier
ndc (package): 17856-1162-1
ndc (product): 17856-1162
ndc11 (package): 17856116201
spl id: 3892f322-6fd8-1a19-e063-6394a90a70fe
spl set id: 308f50dd-e8d6-0264-e063-6394a90afa68

Reported adverse events (FAERS/openFDA)#

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