FDA.reportPublic FDA data

Guaifenesin

Manufacturer
Physicians Total Care, Inc.
Effective date
2012-03-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:31:04

Label at a glance#

ProductGuaifenesin
Active ingredientGUAIFENESIN
Label structure9 sections

Dosage and administration

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

Storage and handling

store at controlled room temperature 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

Use(s)

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

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied 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 illness.

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 
of age and over		1 to 2 tablets every
4 hours
children 6 to under 12 years
of age 

½ to 1 tablet every

4 hours 

children under 6 years of age consult a physician 

Other information

STORAGE AND HANDLING SECTION

  • store at controlled room temperature 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, silica gel, sodium starch glycolate, stearic acid

Questions?

OTC - QUESTIONS SECTION

To Report Adverse Drug Event Call: (800) 616-2471

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

The product packaging shown below represents a sample of that currently in use.  Additional packaging may also be available.
NDC 54868-5847-0
Product Packaging
Product Packaging


 GUAIFENESIN TABLETS
Guaifenesin 200 mg
Expectorant
  • Relieves Chest Congestion
  • Thins and Loosens Mucus
100 Tablets Immediate Release

50844     REV0510A58812

 Distributed by MAJOR PHARMACEUTICALS
31788 Enterprise Drive,
Livonia, MI 48150 USA
Re-Order No. 238163        M-17         Rev. 11/10
 TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma      74146

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
197741guaiFENesin 200 MG Oral TabletPSN1
197741guaifenesin 200 MG Oral TabletSCD1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54868-5847-02019-09-24C16284748780-19350213a-414e-c013-e053-90daa90a1393bf32f7e3-2973-434a-a3c5-7e40bedf5f2a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54868-5847-0Guaifenesin100 in 1 BOTTLE, PLASTICTABLET1001
54868-5847-0Guaifenesin1 in 1 CARTONTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54868-5847GUAIFENESIN TABLET [PHYSICIANS TOTAL CARE, INC.]12 package rows20120305_bf32f7e3-2973-434a-a3c5-7e40bedf5f2a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54868-5847-0EA - Each54868-58473950e823-2341-47a1-8a70-48cec7ec568b12012-07-24
0904-5154-60EA - Each0904-51540d39630a-f133-4d2c-bf29-7ec9c4ac5ca912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
GUAIFENESINACTIVE INGREDIENT495W7451VQ1
GUAIFENESINACTIVE MOIETY495W7451VQ1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2D1
POVIDONEINACTIVE INGREDIENTFZ989GH94E1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54868-584754868-5847-0
0904-5154

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POVIDONEFZ989GH94EIACT
STEARIC ACID4ELV7Z65APIACT

Source Document#

Source XML

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 · 5 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET / ORAL320 mgExact identifier — unii+route+dosage form
POVIDONEPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GuaifenesinGUAIFENESINMajor Pharmaceuticalsaa662428-e61f-4e22-af4d-8cf63df68c992026-06-08WarningsExact identifier
ndc (product): 0904-5154
90123dd1-81e6-42b2-ac2e-c5bae2ed20f7bf32f7e3-2973-434a-a3c5-7e40bedf5f2a2012-03-01WarningsExact identifier
spl id: 90123dd1-81e6-42b2-ac2e-c5bae2ed20f7
spl set id: bf32f7e3-2973-434a-a3c5-7e40bedf5f2a

Reported adverse events (FAERS/openFDA)#

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