FDA.reportPublic FDA data

Galeo

Manufacturer
Cho-A Pharm.Co.,Ltd.
Effective date
2017-02-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:18:00

Label at a glance#

ProductGaleo
Active ingredient4,4'-OXYDI-2-BUTANOL
Label structure8 sections

Indications and uses

Helps relieve symptoms associated with indigestion: such as bloating, nausea, digestive discomfort, eructation.

Dosage and administration

• do not take more than the recommended dose • adults: take 0.5-1g per session, 1-3 times per day, before meal.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Dihydroxydibutylether 5g

Purpose

OTC - PURPOSE SECTION

Digestive aid

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 (1-800-222-1222) right away.

Uses

INDICATIONS & USAGE SECTION

Helps relieve symptoms associated with indigestion: such as bloating, nausea, digestive discomfort, eructation.

Warnings

WARNINGS SECTION

For oral use only

Do not use if you have
• glaucoma
• difficulty in urination, prostate disease ( risk of ischuria)
• billiary atresia
• cholelithiasis
• liver disease
• previously experienced sensitivity to this medication

Ask a doctor, dentist, or pharmacist before use if the user takes
• other medication
• reserpine derivatives
• cholagogue

Stop use and ask a doctor if
• there is no remission of symptoms after several dosages for 2 weeks.

Store at cool temperature and dry place with a closed container. Avoid direct sunlight. - Store in a container other than its original container is equivalent to misuse. In order to prevent the reduction of drug efficacy, keep the product in its original container for storage.

This product contains Sodium Benzoate: it may cause minor irritation on skin, eye, and mucous membrane.

Directions

DOSAGE & ADMINISTRATION SECTION

• do not take more than the recommended dose
• adults: take 0.5-1g per session, 1-3 times per day, before meal.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Sodium Benzoate, D-Sorbitol Solution 70%, Anhydrous Citric Acid, Purified Water

Galeo

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

galeo labelgaleo label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58354-100-022024-06-23C16284748780-19d75b9cf-fd10-f424-e053-dadaa90a57ceGaleo
58354-100-022020-01-31C16284748780-19d75b9cf-fd10-f424-e053-dadaa90a57ceGaleo

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58354-10058354-100-01, 58354-100-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
4,4'-OXYDI-2-BUTANOLCR6X2Y7NRRACTIB
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SORBITOL506T60A25RIACT

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
1b61e15c-f07f-2304-e063-6394a90a34a5be9d1f8c-f7b8-41fc-8c3f-d471dd6534c82024-06-21WarningsExact identifier
spl set id: be9d1f8c-f7b8-41fc-8c3f-d471dd6534c8

Reported adverse events (FAERS/openFDA)#

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