FDA.reportPublic FDA data

Mucus Relief

Manufacturer
PLD Acquisitions LLC DBA Avéma Pharma Solutions
Effective date
2023-02-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:36:59

Label at a glance#

ProductMucus Relief
Active ingredientGUAIFENESIN
Label structure10 sections

Indications and uses

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive.

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 400 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Uses

INDICATIONS & USAGE SECTION

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive.

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough accopanied by too much phlegm (mucus)

Stop use and ask a doctor if

OTC - STOP USE SECTION

cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

SPL UNCLASSIFIED SECTION

  • each tablet contains: sodium 5 mg
  • store between 20-25ºC (68-77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mucus Relief

Guaifenesin 400 mg

Expectorant

  • Relieves chest congestion
  • Thins and loosens mucus

Tablets

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Manufactured by:

Avema Pharma Solutions

10400 NW 29th Terrace

Miami, FL 33172

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mucus Relief
Mucus Relief

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63548-0107-12023-02-09C16284748780-1f386c649-ee2a-0266-e053-dadaa90a7c1aDrug Facts
63548-0107-12023-01-30C16284748780-1f386c649-ee2a-0266-e053-dadaa90a7c1aDrug Facts

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63548-010763548-0107-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POVIDONEFZ989GH94EIACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
STEARIC ACID4ELV7Z65APIACT

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
dc49f6e0-cf0f-477d-9d69-6078d4ccd18d433652b9-3c2b-4e38-aeba-2a8fc4fbb8f92023-02-09WarningsExact identifier
spl id: dc49f6e0-cf0f-477d-9d69-6078d4ccd18d
spl set id: 433652b9-3c2b-4e38-aeba-2a8fc4fbb8f9

Reported adverse events (FAERS/openFDA)#

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