FDA.reportPublic FDA data

Guaifenesin

Manufacturer
Bryant Ranch Prepack
Effective date
2024-03-22
Label type
HUMAN OTC DRUG LABEL
Version
100
Source
legacy-cache
Hydrated at
2026-08-01 21:07:32

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

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

HOW SUPPLIED

How Supplied Section

Guaifenesin 100 mg/5 mL

NDC: 72162-1671-2: 473 mL in a BOTTLE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Guaifenesin 100mg/5mL Oral Liquid #473

Label
Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1671-2ML - Milliliter72162-16714c4553ce-7378-4d99-920a-db844472a8ac12024-08-12
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
72162-167172162-1671-2
58657-509

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
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GuaifenesinGUAIFENESINMethod Pharmaceuticals, LLC312ce620-4841-7488-e054-00144ff88e882025-10-21WarningsExact identifier
ndc (product): 58657-509
8c12e20f-7c04-4a10-8d97-d57c7de0d108ba223414-2663-4e99-9f38-030ca2d949fa2024-08-26WarningsExact identifier
spl set id: ba223414-2663-4e99-9f38-030ca2d949fa

Reported adverse events (FAERS/openFDA)#

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