MedPath

mucus relief dm

Meijer Distribution, Inc. Mucus Relief DM Drug Facts

Approved
Approval ID

d41749b4-735b-44f7-ab06-244f68e031e3

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 7, 2025

Manufacturers
FDA

Meijer Distribution Inc

DUNS: 006959555

Products 1

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

dextromethorphan hydrobromide, guaifenesin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code41250-436
Application NumberANDA207602
Product Classification
M
Marketing Category
C73584
G
Generic Name
dextromethorphan hydrobromide, guaifenesin
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2025
FDA Product Classification

INGREDIENTS (10)

DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 30 mg in 1 1
Code: 9D2RTI9KYH
Classification: ACTIB
GUAIFENESINActive
Quantity: 600 mg in 1 1
Code: 495W7451VQ
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED)Inactive
Code: K6MOM3T5YL
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM HYDROXIDEInactive
Code: NBZ3QY004S
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/7/2025

Package/Label Principal Display Panel

meijer®

COMPARE TO MUCINEX® DM ACTIVE INGREDIENTS

Mucus Relief DM

Guaifenesin 600 mg & Dextromethorphan Hydrobromide 30 mg Extended-Release Tablets

Expectorant/Cough Suppressant

12 HOUR

CONTROLS COUGH

THINS AND LOOSENS MUCUS

20 EXTENDED-RELEASE TABLETS

Actual Size

![meijer-mucus-relief-dm-carton-image.jpg](/dailymed/image.cfm?name=meijer- mucus-relief-dm-carton-image.jpg&id=874870)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/27/2020

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: 1/27/2020

Active ingredients (in each extended-release tablet)

Dextromethorphan HBr 30 mg

Guaifenesin 600 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 1/27/2020

Purposes

Cough suppressant

Expectorant

WARNINGS SECTION

LOINC: 34071-1Updated: 1/27/2020

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: 1/27/2020

Directions

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:

1 or 2 tablets every 12 hours; not more than 4 tablets in 24 hours

children under 12 years of age: do not use

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 5/7/2025

Other information

**each tablet contains:** magnesium 15 mg

Do not use if printed foil under cap is broken or missing.

store between 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/27/2020

Inactive ingredients

carbomer homopolymer type B, copovidone, D&C yellow #10 aluminum lake, hypromellose, magnesium hydroxide, magnesium stearate, microcrystalline cellulose, silicon dioxide

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/7/2025

Questions or comments?

1-800-719-9260

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

mucus relief dm - FDA Drug Approval Details