FDA.reportPublic FDA data

Guaifenesin

Manufacturer
Method Pharmaceuticals, LLC
Effective date
2025-10-21
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:41:12

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 2 to 4 teaspoonfuls  12 years and over every 4 hours  children 6 years to 1 to 2 teaspoonfuls  under 12 years every 4 hours  children 2 years to ½ to 1 teaspoonful  under 6 years every 4 hours  children under 2 years ask a doctor Drug Facts (continued)

Storage and handling

store at 20°-25°C (68°-77°F) packaged with tamper evident seal under cap

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

NDC 58657-509-16

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

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 
    age dose adults and children 2 to 4 teaspoonfuls 
    12 years and over every 4 hours 
    children 6 years to 1 to 2 teaspoonfuls 
    under 12 years every 4 hours 
    children 2 years to ½ to 1 teaspoonful 
    under 6 years every 4 hours 
    children under 2 years ask a doctor

Drug Facts(continued)

Other information

STORAGE AND HANDLING SECTION

  • store at 20°-25°C (68°-77°F)
  • packaged with tamper evident seal under cap

Inactive ingredients

INACTIVE INGREDIENT SECTION

Bitter Mask, Cherry Flavor, Citric Acid, FD&C Red#40, Glycerin, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol Solution

Questions or Comments

OTC - QUESTIONS SECTION

1-877-250-3427

Manufactured For:
Method Pharmaceuticals, LLC
Fort Worth, Texas 76118 Rev. 09/16

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58657- 509- 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 SolutionPSN9
310604guaifenesin 20 MG/ML Oral SolutionSCD9
310604guaifenesin 100 MG per 5 ML Oral SolutionSY9
310604guaifenesin 100 MG per 5 ML Oral SyrupSY9
310604guaifenesin 200 MG per 10 ML Oral SolutionSY9
310604guaifenesin 300 MG per 15 ML Oral SolutionSY9
310604guaifenesin 400 MG per 20 ML Oral SolutionSY9

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58657-509-16Guaifenesin473 mL in 1 BOTTLELIQUID4739

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-509-16ML - Milliliter58657-5093ae23965-f0cf-41d6-95fe-ed03df86f2e112016-06-14

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58657-50958657-509-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
GUAIFENESIN495W7451VQACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82024-11-29full-release2026-06-01 00:39:51

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, LLC312ce620-4841-7488-e054-00144ff88e882025-10-21WarningsExact identifier
ndc (package): 58657-509-16
ndc (product): 58657-509
ndc11 (package): 58657050916
spl id: 41b52068-d18f-5c54-e063-6394a90aa503
spl set id: 312ce620-4841-7488-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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