FDA.reportPublic FDA data

Major 44-588

Manufacturer
Major Pharmaceuticals | LNK International, Inc.
Effective date
2026-06-08
Label type
HUMAN OTC DRUG LABEL
Version
27
Source
daily-update
Hydrated at
2026-06-11 05:11:19

Label at a glance#

ProductGuaifenesin
Active ingredientGUAIFENESIN
Label structure9 sections

Indications and uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Dosage and administration

do not exceed 6 doses in 24 hours take with a full glass of water adults and children 12 years and over 1 to 2 tablets every 4 hours children 6 to under 12 years ½ to 1 tablet every 4 hours children under 6 years ask a doctor

Storage and handling

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) use by expiration date on package

Label contents#

Full prescribing information#

Active ingredient (in each immediate-release tablet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 200 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 make coughs more productive

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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,

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 doses in 24 hours
  • take with a full glass of water
adults and children 12 years and over1 to 2 tablets every 4 hours
children 6 to under 12
years

½ to 1 tablet every 4 hours

children under 6 years
ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • use by expiration date on package

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C red #40 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR®                             NDC 0904-5154-60

immediate release
guaifenesin

guaifenesin 200 mg
expectorant

•relieves chest congestion
•thins and loosens mucus

actual size

100 tablets

MAJOR 44-588
MAJOR 44-588

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130309045154601GTIN-13: 0309045154601
EAN-13: 0309045154601
GTIN-12: 309045154601
UPC-A: 309045154601
GTIN storage (14 digits): 00309045154601		major-44-588-1.jpg

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5154-60EA - Each0904-51540d39630a-f133-4d2c-bf29-7ec9c4ac5ca912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
GUAIFENESINACTIVE INGREDIENT495W7451VQ13
GUAIFENESINACTIVE MOIETY495W7451VQ13
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I3013
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2D13
POVIDONESINACTIVE INGREDIENTFZ989GH94E13
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP13

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
0904-51540904-5154-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
FD&C RED NO. 40 ALUMINUM LAKE6T47AS764TIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
262025-06-02full-release2026-06-01 01:02:08

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 10 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POVIDONESPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET / ORAL320 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET / ORAL320 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
GuaifenesinGUAIFENESINMajor Pharmaceuticalsaa662428-e61f-4e22-af4d-8cf63df68c992026-06-08WarningsExact identifier
ndc (package): 0904-5154-60
ndc (product): 0904-5154
ndc11 (package): 00904515460
spl id: 9a9743de-1619-4d95-868f-d125b1d409e4
spl set id: aa662428-e61f-4e22-af4d-8cf63df68c99

Reported adverse events (FAERS/openFDA)#

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