FDA.reportPublic FDA data

Guaifenesin

Manufacturer
Method Pharmaceuticals, LLC
Effective date
2025-10-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:41:07

Label at a glance#

ProductGuaifenesin
Active ingredientGUAIFENESIN
Label structure10 sections

Indications and uses

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

Dosage and administration

do not take more than 6 doses in any 24-hour period age dose adults and children 12 years and over 2 to 4 teaspoonfuls every 4 hours children 6 years to under 12 years 1 to 2 teaspoonfuls every 4 hours children 2 to under 6 yars 1/2 to 1 teaspoonful every 4 hours children under 2 years ask a doctor

Storage and handling

store at 20°-25°C (68°-77°F) packaged with tamper evident seal under cap each 5 mL contains: sodium 3 mg

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

NDC 58657-508-16

Guaifenesin

Liquid USP

100 mg/5 Ml

Expectorant

Sugar Free • Alcohol Free

Cherry Flavor

Loosens and Relieves Chest Congestion

16 fl. oz. (473 mL)

Drug Facts

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 100 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

When using this product

OTC - WHEN USING SECTION

  • Do not use more than directed

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.

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 take more than 6 doses in any 24-hour period
    agedose
    adults and children 12 years and over2 to 4 teaspoonfuls every 4 hours
    children 6 years to under 12 years1 to 2 teaspoonfuls every 4 hours
    children 2 to under 6 yars1/2 to 1 teaspoonful every 4 hours
    children under 2 yearsask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 20°-25°C (68°-77°F)
  • packaged with tamper evident seal under cap
  • each 5 mL contains: sodium 3 mg

Inactive ingredients

INACTIVE INGREDIENT SECTION

Caramel, citric acid anhydrous, dextrose, FD&C red #40, flavor, gylcerin, high fructose corn syrup, menthol, purified water, saccharin, sodium, sodium benzoate

Questions or Comments

OTC - QUESTIONS SECTION

1-877-250-3427

Manufactured For:
Method Pharmaceuticals, LLC
Southlake, TX 79092

LR-205

Rev-2024

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58657- 508- 16

Guaifenesin

Liquid USP

100 mg/ 5 mL

Expectorant

16 fl. oz. (473 mL)

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN3
310604guaifenesin 20 MG/ML Oral SolutionSCD3
310604guaifenesin 100 MG per 5 ML Oral SolutionSY3
310604guaifenesin 100 MG per 5 ML Oral SyrupSY3
310604guaifenesin 200 MG per 10 ML Oral SolutionSY3
310604guaifenesin 300 MG per 15 ML Oral SolutionSY3
310604guaifenesin 400 MG per 20 ML Oral SolutionSY3

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58657-508-16Guaifenesin473 mL in 1 BOTTLELIQUID4733

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-508-16ML - Milliliter58657-5086867c51f-6f8f-4f97-b3cd-09026f75630c12024-05-16

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58657-50858657-508-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AIACT
CARAMELT9D99G2B1RIACT
DEXTROSEIY9XDZ35W2IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
GUAIFENESIN495W7451VQACTIB
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-04-01full-release2026-06-01 00:12:10

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
GuaifenesinGUAIFENESINMethod Pharmaceuticals, LLC1539c3d4-d982-7d4e-e063-6394a90ad7d62025-10-21WarningsExact identifier
ndc (package): 58657-508-16
ndc (product): 58657-508
ndc11 (package): 58657050816
spl id: 41b51a4b-65a5-778b-e063-6294a90ae4a9
spl set id: 1539c3d4-d982-7d4e-e063-6394a90ad7d6

Reported adverse events (FAERS/openFDA)#

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