MedPath

Mucus Relief DM Extended Release Caplets

Drug Facts

Approved
Approval ID

62cd2d77-abcb-4848-8d17-cf8c67216373

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 20, 2025

Manufacturers
FDA

Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)

DUNS: 068331990

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Guaifenesin, Dextromethorphan HBr

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55910-634
Application NumberANDA209692
Product Classification
M
Marketing Category
C73584
G
Generic Name
Guaifenesin, Dextromethorphan HBr
Product Specifications
Route of AdministrationORAL
Effective DateAugust 20, 2025
FDA Product Classification

INGREDIENTS (11)

DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 60 mg in 1 1
Code: 9D2RTI9KYH
Classification: ACTIB
GUAIFENESINActive
Quantity: 1200 mg in 1 1
Code: 495W7451VQ
Classification: ACTIB
CARBOMER 934Inactive
Code: Z135WT9208
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/20/2025

Package Label

![Dextromethorphan HBr 60 mg, Guaifenesin 1200 mg](/dailymed/image.cfm?name=mucus-relief-dm-1200-mg-60-mg-extended-release- cap-1.jpg&id=894008)

DOLLAR GENERAL Maximum Strength Mucus Relief DM

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/20/2025

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/20/2025

Active ingredients (in each extended-release tablet)

Dextromethorphan HBr 60 mg

Guaifenesin 1200 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/20/2025

Purpose

Cough Suppressant

Expectorant

WARNINGS SECTION

LOINC: 34071-1Updated: 8/20/2025

Warnings

Do not use

  • for children under 12 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

  • 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,

do not use more than directed.

Stop use and ask a doctor if

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,

ask a health professional before use.

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/20/2025

Directions

  • 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 SECTION

LOINC: 44425-7Updated: 8/20/2025

Other information

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/20/2025

Inactive ingredients

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/20/2025

Questions or comments?

Call** 1-888-309-9030**

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