FDA.reportPublic FDA data

GUAIFENESIN

Manufacturer
Cardinal Health 107, LLC
Effective date
2026-06-18
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
weekly-update
Hydrated at
2026-07-17 21:41:48

Label at a glance#

ProductGUAIFENESIN
Active ingredientGUAIFENESIN
Label structure11 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.
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

SPL UNCLASSIFIED SECTION

Guaifenesin Oral Solution USP is a red, raspberry flavored solution supplied in the following oral dosage forms:

Overbagged with 5 x 5 mL unit dose cups in each bag, NDC 55154-9450-5

Overbagged with 5 x 10 mL unit dose cups in each bag, NDC 55154-5780-5

WARNING: These Unit Dose packages are not child resistant and are Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Distributed By:

Cardinal Health

Dublin, OH 43017

L54670551025

L53963871025

R04/05 F1744050221 F1744100221 F1744150221

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

NDC 55154-9450-5

GUAIFENESIN ORAL SOLUTION USP

100 mg/5mL

5 CUPS

100mg/5mL bag label
100mg/5mL bag label

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 55154-5780-5

GUAIFENESIN ORAL SOLUTION USP

200 mg/10 mL

5 CUPS

200mg/10mL bag label
200mg/10mL bag label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130055154578059GTIN-13: 0055154578059
EAN-13: 0055154578059
GTIN-12: 055154578059
UPC-A: 055154578059
GTIN storage (14 digits): 00055154578059		25a970c7-0016-4f22-9e94-1e20e1319e3e-00.jpg
BarcodeEAN-130055154945059GTIN-13: 0055154945059
EAN-13: 0055154945059
GTIN-12: 055154945059
UPC-A: 055154945059
GTIN storage (14 digits): 00055154945059		365011d4-ff31-423f-a6f1-d1e2fd402c5d-00.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
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
0121-1488-00ML - Milliliter0121-14884edf1700-20c9-4897-926a-e4b26d9307ed12018-01-12
0121-1488-10ML - Milliliter0121-148865e68bfd-3e4b-48bf-a152-400ab8deb4cd12018-01-12

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
55154-945055154-9450-5
0121-1744
55154-578055154-5780-5
0121-1488

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
ACESULFAME POTASSIUM23OV73Q5G9IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C GREEN NO. 33P3ONR6O1SIACT
FD&C RED NO. 40WZB9127XOAIACT
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
GUAIFENESIN495W7451VQACTIB
ACESULFAME POTASSIUM23OV73Q5G9IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C GREEN NO. 33P3ONR6O1SIACT
FD&C RED NO. 40WZB9127XOAIACT
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
102025-11-07full-release2026-06-01 01:43:36
82024-01-09full-release2026-06-01 00:07:02

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
GUAIFENESINGUAIFENESINCardinal Health 107, LLC888b6a2e-6631-4585-a7fe-eb122eb51b232026-06-18WarningsExact identifier
ndc (package): 55154-9450-5
ndc (package): 55154-5780-5
ndc (product): 55154-9450
ndc (product): 55154-5780
ndc11 (package): 55154945005
ndc11 (package): 55154578005
spl id: 39be0662-6709-447d-977f-8ab2af20c742
spl set id: 888b6a2e-6631-4585-a7fe-eb122eb51b23
GUAIFENESINGUAIFENESINPAI Holdings, LLC dba PAI Pharmac2e53fb5-2798-47c8-9285-d1077d46e6292022-06-14WarningsExact identifier
ndc (product): 0121-1488
ndc (product): 0121-1744

Reported adverse events (FAERS/openFDA)#

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