MedPath

Mucus Relief D

Meijer 44-547

Approved
Approval ID

383281d7-0d25-4423-ace2-d2985f2c37d0

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 26, 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.

Guaifenesin, Pseudoephedrine HCl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code41250-547
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Guaifenesin, Pseudoephedrine HCl
Product Specifications
Route of AdministrationORAL
Effective DateAugust 26, 2025
FDA Product Classification

INGREDIENTS (11)

GUAIFENESINActive
Quantity: 400 mg in 1 1
Code: 495W7451VQ
Classification: ACTIB
PSEUDOEPHEDRINE HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: 6V9V2RYJ8N
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/26/2025

Principal Display Panel

NDC 41250-547-72

meijer®

mucus
****relief D
****Guaifenesin | Pseudoephedrine HCl
Expectorant | Nasal Decongestant

27 Tablets | actual size

Clears Nasal/
Sinus Congestion
Thins & Loosens Mucus

Immediate Release

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

50844 REV0419A54772

DIST. BY MEIJER
** DISTRIBUTION, INC.**
** GRAND RAPIDS, MI 49544**
****www.meijer.com

OUR QUALITY
** GUARANTEE**
The Meijer
** Family
******
********WWW.MEIJER.COM/SATISFACTIONMeijer 44-547

Meijer 44-547

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/26/2025

Uses

  • temporarily relieves sinus congestion and pressure
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • promotes nasal and/or sinus drainage
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/26/2025

Active ingredients****(in each immediate-release tablet)****

Guaifenesin 400 mg
Pseudoephedrine HCl 40 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/26/2025

Purpose

Expectorant
Nasal decongestant

WARNINGS SECTION

LOINC: 34071-1Updated: 8/26/2025

Warnings

Do not use

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

  • cough accompanied by too much phlegm (mucus)
  • heart disease
  • thyroid disease
  • difficulty in urination due to enlargement of the prostate gland
  • high blood pressure
  • diabetes
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or are accompanied by fever
  • cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.

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 (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/26/2025

Directions

  • adults and children 12 years and over: take 1 tablet every 4 hours, with a full glass of water, while symptoms persist. Do not exceed 6 tablets in 24 hours.
  • children under 12 years: do not use

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 8/26/2025

Other information

  • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F) *TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

  • see end flap for expiration date and lot number

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/26/2025

Inactive ingredients

hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/26/2025

Questions or comments?

1-800-426-9391

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