Mucus Relief Xpect

Manufacturer
Midway Importing Inc. | Selder, S.A. de C.V.
Effective date
2024-10-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:30:00

Label at a glance#

ProductMucus Relief Xpect
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure9 sections

Indications and uses

■ helps loosen phlegm (mucus) ■ helps thin bronchial secretions to make coughs more productive ■ temporarily relieves cough due to minor sore throat and bronchial irritation associated with the common cold.

Dosage and administration

Adults and children 12 years and older: take 1 tablet every 4 hours with a full glass of water while symptoms persist. ■ Do not exceed 6 doses in 24 hours. Children under 12 years of age: do not use.

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 400mg
Dextromethorphan HBr 20mg

Purposes

OTC - PURPOSE SECTION

Expectorant
Cough suppressant

Uses

INDICATIONS & USAGE SECTION

■ helps loosen phlegm (mucus) ■ helps thin bronchial secretions to make coughs more productive ■ temporarily relieves cough due to minor sore throat and bronchial irritation associated with the common cold.

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

■ 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 a MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

■ cough accompanied by excessive phlegm (mucus) ■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema.

Ask a doctor or pharmacist before use if you

OTC - ASK DOCTOR/PHARMACIST SECTION

■ are taking sedatives or tranquilizers.

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache.

These could be signs of a serious condition.

Pregnancy/Breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and older: take 1 tablet every 4 hours with a full glass of water while symptoms persist. ■ Do not exceed 6 doses in 24 hours. Children under 12 years of age: do not use.

Other information

SPL UNCLASSIFIED SECTION

■ store at 25°C (77°F) excursions between 15°-30°C (59°-86°F) ■ Keep in a dry place and do not expose to heat ■ do not use if blister package is torn or damaged.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

alcohol, colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate (derived from milk), magnesium stearate, polyethylene glycol, povidone, purified water, stearic acid

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1-855-259-1590 Monday through Friday 9 AM - 5 PM EST.

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1147685dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral TabletPSN3
1147685dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral TabletSCD3
1147685guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral TabletSY3

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
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76095-012-20Mucus Relief Xpect10 in 1 BLISTER PACKTABLET103
76095-012-20Mucus Relief Xpect2 in 1 CARTONTABLET23
76095-012-30Mucus Relief Xpect3 in 1 CARTONTABLET33
76095-012-30Mucus Relief Xpect10 in 1 BLISTER PACKTABLET103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76095-012MUCUS RELIEF XPECT (GUAIFENSIN, DEXTROMETHORPHAN) TABLET [MIDWAY IMPORTING INC.]3Current NDC, Legacy NDC, 4 package rows20241027_c2c8bd26-bbf1-c2e6-e053-2995a90a86a7.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76095-01276095-012-20, 76095-012-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucus Relief XpectGUAIFENSIN, DEXTROMETHORPHANMidway Importing Inc.c2c8bd26-bbf1-c2e6-e053-2995a90a86a72024-10-17WarningsExact identifier
ndc (package): 76095-012-30
ndc (package): 76095-012-20
ndc (product): 76095-012
ndc11 (package): 76095001230
ndc11 (package): 76095001220
spl id: 24b26929-2f23-e5e7-e063-6394a90af59a
spl set id: c2c8bd26-bbf1-c2e6-e053-2995a90a86a7

Reported adverse events (FAERS/openFDA)#

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