FDA.reportPublic FDA data

Guaifenesin

Manufacturer
Cardinal Health
Effective date
2018-01-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 01:03:45

Label at a glance#

ProductGuaifenesin
Active ingredientGUAIFENESIN
Label structure9 sections

Indications and uses

Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Dosage and administration

Follow dosage below or use as directed by a physician. • do not take more than 6 doses in any 24-hour period. age dose adults and children 12 years and over 10 to 20 mL (2 to 4 teaspoonfuls) every 4 hours children 6 years to under 12 years 5 to 10 mL (1 to 2 teaspoonfuls) every 4 hours children 2 to under 6 years of age 2.5 to 5 mL (½ to 1 teaspoonful) every 4 hours children under 2 years of age consult a physician

Storage and handling

Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). [See USP] Protect from light.

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Expectorant
SUGAR FREE / ALCOHOL FREE

DESCRIPTION

OTC - ACTIVE INGREDIENT SECTION

Each 5 mL (1 teaspoonful) contains:
Guaifenesin 100 mg

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acesulfame K, citric acid, FD&C Green No. 3, FD&C Red No. 40, flavoring, hydroxyethylcellulose, purified water, sodium benzoate and sodium citrate.

Sodium Content: 4 mg/5 mL

USES

INDICATIONS & USAGE SECTION

Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

WARNINGS

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
  • you are hypersensitive to any of the ingredients.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Professional Note

SPL UNCLASSIFIED SECTION

Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Follow dosage below or use as directed by a physician.

  • do not take more than 6 doses in any 24-hour period.
agedose

adults and children 12 years and over

10 to 20 mL
(2 to 4 teaspoonfuls)
every 4 hours

children 6 years to under 12 years

5 to 10 mL
(1 to 2 teaspoonfuls)
every 4 hours

children 2 to under 6 years of age

2.5 to 5 mL
(½ to 1 teaspoonful)
every 4 hours

children under 2 years of age

consult a physician

STORAGE

STORAGE AND HANDLING SECTION

Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). [See USP] Protect from light.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Guaifenesin Oral Solution USP

100 mg/5mL

5 Cups

bag label
bag label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-1744-00ML - Milliliter0121-1744171bdc6a-7b5f-45a7-87e1-b202b3ef5ad412018-01-12
0121-1744-05ML - Milliliter0121-174480ee20cf-4e2b-4882-bcd2-cbd2ec3f467112014-10-03
0121-1744-10ML - Milliliter0121-174429730dba-fb62-49e5-b8f8-98345a3002ea12014-10-03
0121-1744-15ML - Milliliter0121-17448868bbf3-ee16-4fa4-8362-f51827a901a012014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
GUAIFENESINACTIVE INGREDIENT495W7451VQ3
GUAIFENESINACTIVE MOIETY495W7451VQ3
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G93
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP3
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1S3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA3
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)INACTIVE INGREDIENTS38J6RZN163
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR3
WATERINACTIVE INGREDIENT059QF0KO0R3

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
55154-943755154-9437-5
0121-1744

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
ACESULFAME POTASSIUM23OV73Q5G9IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C GREEN NO. 33P3ONR6O1SIACT
FD&C RED NO. 40WZB9127XOAIACT
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT

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 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+route+dosage form
FD&C GREEN NO. 3FD&C GREEN NO. 33P3ONR6O1SSOLUTION / ORAL0.25 mg/5mlExact identifier — unii+route+dosage form
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / ORAL446 mgExact identifier — unii+route+dosage form
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9SOLUTION / ORAL400 mgExact identifier — unii+route+dosage form
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SOLUTION / ORAL3 mgExact identifier — unii+route+dosage form
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 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
GUAIFENESINGUAIFENESINPAI Holdings, LLC dba PAI Pharmac2e53fb5-2798-47c8-9285-d1077d46e6292022-06-14WarningsExact identifier
ndc (product): 0121-1744
b343fec4-f543-4399-8687-872e247ceeebece21b53-3c85-43e3-852b-7745cf83ef6e2019-11-06WarningsExact identifier
spl set id: ece21b53-3c85-43e3-852b-7745cf83ef6e

Reported adverse events (FAERS/openFDA)#

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