FDA.reportPublic FDA data

Guaifenesin Oral Solution USP Drug Facts

Manufacturer
American Health Packaging
Effective date
2024-10-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:27:38

Label at a glance#

ProductGuaifenesin
Active ingredientGUAIFENESIN
Label structure15 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 (yr) Dose (ml) 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 years to under 6 years 2.5 to 5 ml (1 /2 to 1 teaspoonful) every 4 hours children under 2 years consult a physi...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Expectorant
SUGAR FREE / ALCOHOL FREE

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

  • (in each 5 mL Cup)      Guaifenesin 100 mg
  • (in each 10 mL Cup)      Guaifenesin 200 mg
  • (in each 15 mL Cup)      Guaifenesin 300 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

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.

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

Follow dosage below or use as directed by a physician.

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

Age (yr)

Dose (ml)

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 years to under 6 years

2.5 to 5 ml (1 /2 to 1 teaspoonful) every 4 hours

children under 2 years

consult a physician

Other Information

OTHER SAFETY INFORMATION

  • Each 5 ml contains: sodium 4 mg.
  • Each 10 ml contains: sodium 8 mg.
  • Each 15 ml contains: sodium 12 mg.
  • Store at controlled room temperature between 20° to 25°C (68° to 77°F) [see USP]. Protect from light.
  • DO NOT USE IF SEAL IS BROKEN.
  • Guaifenesin Oral Solution is a red, raspberry flavored solution and is available in the following dosage forms:
    5 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-852-17
    10 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-863-56
    15 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-874-16

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.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-845-8210

Generic Section

SPL UNCLASSIFIED SECTION

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

Distributed by:
American Health Packaging
Columbus, OH 43217

R0624

Package/Label Principal Display Panel – 100 mg per 5 mL – Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 mg per 5 mL Guaifenesin Oral Solution Label100 mg per 5 mL Guaifenesin Oral Solution Label

Case NDC 60687- 852-17/Cup NDC 60687- 852-40

Guaifenesin
Oral Solution USP
Expectorant

100 mg per 5 ml

SUGAR FREE / ALCOHOL FREE
Raspberry Flavor

Usual Dosage: See attached Drug Facts.

Store at 20° to 25°C (68° to 77°F) [See USP]
Protect from light.

FOR INSTITUTIONAL USE ONLY

T0744C050624                 R0624

Package/Label Principal Display Panel – 100 mg per 5 mL – Cup Lid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 mg per 5 mL Guaifenesin Oral Solution Cup Lid100 mg per 5 mL Guaifenesin Oral Solution Cup Lid

NDC 60687- 852-40

Guaifenesin
Oral Solution, USP
Expectorant

100 mg per 5 ml

Sugar Free/Alcohol Free
Delivers 5 mL

PROTECT FROM LIGHT.

See package Drug Facts insert for full
prescribing information and storage.

For Institutional Use Only.

American Health Packaging
Columbus, OH 43217

F0744C050624

Package/Label Principal Display Panel – 200 mg per 10 mL – Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

200 mg per 5 mL Guaifenesin Oral Solution Label200 mg per 5 mL Guaifenesin Oral Solution Label

Case NDC 60687- 863-56/Cup NDC 60687- 863-42

Guaifenesin
Oral Solution USP
Expectorant

200 mg per 10 ml

Sodium Content: 8 mg/10 ml
SUGAR FREE / ALCOHOL FREE
Raspberry Flavor

Usual Dosage: See attached Drug Facts.

Store at 20° to 25°C (68° to 77°F) [See USP]
Protect from light.

FOR INSTITUTIONAL USE ONLY

T0744C100624                 R0624

Package/Label Principal Display Panel – 200 mg per 10 mL – Cup Lid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

200 mg per 5 mL Guaifenesin Oral Solution Cup Lid200 mg per 5 mL Guaifenesin Oral Solution Cup Lid

NDC 60687- 863-42

Guaifenesin
Oral Solution, USP
Expectorant

200 mg per 10 ml

Sodium Content: 8 mg/10 ml
Sugar Free/Alcohol Free
Delivers 10 mL

PROTECT FROM LIGHT.

See package Drug Facts insert for full
prescribing information and storage.

For Institutional Use Only.

American Health Packaging
Columbus, OH 43217

F0744C100624

Package/Label Principal Display Panel – 300 mg per 15 mL – Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

300 mg per 5 mL Guaifenesin Oral Solution Label300 mg per 5 mL Guaifenesin Oral Solution Label

Case NDC 60687- 874-16/Cup NDC 60687- 874-44

Guaifenesin
Oral Solution USP
Expectorant

300 mg per 15 ml

Sodium Content: 12 mg/15 ml
SUGAR FREE / ALCOHOL FREE
Raspberry Flavor

Usual Dosage: See attached Drug Facts.

Store at 20° to 25°C (68° to 77°F) [See USP]
Protect from light.

FOR INSTITUTIONAL USE ONLY

T0744C150624                 R0624

Package/Label Principal Display Panel – 300 mg per 15 mL – Cup Lid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

300 mg per 5 mL Guaifenesin Oral Solution Cup Lid300 mg per 5 mL Guaifenesin Oral Solution Cup Lid

NDC 60687- 874-44

Guaifenesin
Oral Solution, USP
Expectorant

300 mg per 15 ml

Sodium Content: 12 mg/15 ml
Sugar Free/Alcohol Free
Delivers 15 mL

PROTECT FROM LIGHT.

See package Drug Facts insert for full
prescribing information and storage.

For Institutional Use Only.

American Health Packaging
Columbus, OH 43217

F0744C150624

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN1
310604guaifenesin 20 MG/ML Oral SolutionSCD1
310604guaifenesin 100 MG per 5 ML Oral SolutionSY1
310604guaifenesin 100 MG per 5 ML Oral SyrupSY1
310604guaifenesin 200 MG per 10 ML Oral SolutionSY1
310604guaifenesin 300 MG per 15 ML Oral SolutionSY1
310604guaifenesin 400 MG per 20 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-852-17Guaifenesin10 in 1 CASESOLUTION101
60687-852-40Guaifenesin5 mL in 1 CUP, UNIT-DOSESOLUTION51
60687-852-46Guaifenesin10 in 1 TRAYSOLUTION101
60687-863-42Guaifenesin10 mL in 1 CUP, UNIT-DOSESOLUTION101
60687-863-48Guaifenesin10 in 1 TRAYSOLUTION101
60687-863-56Guaifenesin10 in 1 CASESOLUTION101
60687-874-16Guaifenesin10 in 1 CASESOLUTION101
60687-874-44Guaifenesin15 mL in 1 CUP, UNIT-DOSESOLUTION151
60687-874-50Guaifenesin10 in 1 TRAYSOLUTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-852GUAIFENESIN SOLUTION [AMERICAN HEALTH PACKAGING]1Current NDC, 3 package rows20241021_2fd702ea-3069-472c-b99e-c527f1375705.zip
60687-863GUAIFENESIN SOLUTION [AMERICAN HEALTH PACKAGING]1Current NDC, 3 package rows20241021_2fd702ea-3069-472c-b99e-c527f1375705.zip
60687-874GUAIFENESIN SOLUTION [AMERICAN HEALTH PACKAGING]1Current NDC, 3 package rows20241021_2fd702ea-3069-472c-b99e-c527f1375705.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-852-17ML - Milliliter60687-8524a65c2b5-de11-422b-83ae-f0f3e9d7146812024-11-05
60687-852-40ML - Milliliter60687-852459738a7-6ab0-4aa9-b321-6b3515eb703e12024-11-05
60687-863-42ML - Milliliter60687-86316653323-3699-46bd-ad9d-7089cdb291dd12024-11-05
60687-863-56ML - Milliliter60687-863ad69ee57-8bbc-4475-9837-f199a46433c212024-11-05
60687-874-16ML - Milliliter60687-874eedfb90d-06ee-43b9-8eb9-013bd1ad669e12024-11-05
60687-874-44ML - Milliliter60687-874eaa67b25-76d7-46d7-a990-5e415e4d365e12024-11-05

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
60687-85260687-852-40, 60687-852-46, 60687-852-17
60687-86360687-863-42, 60687-863-48, 60687-863-56
60687-87460687-874-44, 60687-874-50, 60687-874-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACESULFAME POTASSIUM23OV73Q5G9IACT
FD&C GREEN NO. 33P3ONR6O1SIACT
FD&C RED NO. 40WZB9127XOAIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GUAIFENESIN495W7451VQACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
ACESULFAME POTASSIUM23OV73Q5G9IACT
FD&C GREEN NO. 33P3ONR6O1SIACT
FD&C RED NO. 40WZB9127XOAIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
GUAIFENESIN495W7451VQACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
ACESULFAME POTASSIUM23OV73Q5G9IACT
FD&C GREEN NO. 33P3ONR6O1SIACT
FD&C RED NO. 40WZB9127XOAIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
GUAIFENESIN495W7451VQACTIB

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
GuaifenesinGUAIFENESINAmerican Health Packaging2fd702ea-3069-472c-b99e-c527f13757052024-10-17WarningsExact identifier
ndc (package): 60687-874-16
ndc (package): 60687-852-17
ndc (package): 60687-863-48
ndc (package): 60687-852-46
ndc (package): 60687-863-42
ndc (package): 60687-874-44
ndc (package): 60687-852-40
ndc (package): 60687-874-50
ndc (package): 60687-863-56
ndc (product): 60687-863
ndc (product): 60687-874
ndc (product): 60687-852
ndc11 (package): 60687087444
ndc11 (package): 60687086356
ndc11 (package): 60687087450
ndc11 (package): 60687085240
ndc11 (package): 60687085246
ndc11 (package): 60687086342
ndc11 (package): 60687086348
ndc11 (package): 60687087416
ndc11 (package): 60687085217
spl id: 24b1b6f4-c113-8adc-e063-6394a90a546c
spl set id: 2fd702ea-3069-472c-b99e-c527f1375705

Reported adverse events (FAERS/openFDA)#

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