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FDA Approval

mucus relief dm

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
May 7, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Dextromethorphan(30 mg in 1 1)
Guaifenesin(600 mg in 1 1)

Products1

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

mucus relief dm

Product Details

NDC Product Code
41250-436
Application Number
ANDA207602
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
May 7, 2025
Code: 9D2RTI9KYHClass: ACTIBQuantity: 30 mg in 1 1
Code: 495W7451VQClass: ACTIBQuantity: 600 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED)Inactive
Code: K6MOM3T5YLClass: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8BClass: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM HYDROXIDEInactive
Code: NBZ3QY004SClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

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 & ADMINISTRATION SECTION

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

WARNINGS SECTION

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)


OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each extended-release tablet)

Dextromethorphan HBr 30 mg

Guaifenesin 600 mg

OTC - PURPOSE SECTION

Purposes

Cough suppressant

Expectorant

OTC - QUESTIONS SECTION

Questions or comments?

1-800-719-9260


OTHER SAFETY INFORMATION

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

Inactive ingredients

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


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