GALEO- dihydroxydibutylether liquid

Galeo by

Drug Labeling and Warnings

Galeo by is a Otc medication manufactured, distributed, or labeled by Cho-A Pharm.Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Dihydroxydibutylether 5g

Purpose

Digestive aid

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Uses

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

Warnings

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

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

Inactive Ingredients

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

Galeo

INGREDIENTS AND APPEARANCE

GALEO 
dihydroxydibutylether liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58354-100
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
4,4'-OXYDI-2-BUTANOL (UNII: CR6X2Y7NRR) (4,4'-OXYDI-2-BUTANOL - UNII:CR6X2Y7NRR)	4,4'-OXYDI-2-BUTANOL	5 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SORBITOL (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58354-100-02	1 in 1 PACKAGE	02/28/2017
1	NDC: 58354-100-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/28/2017

Labeler - Cho-A Pharm.Co.,Ltd. (688056831)

Registrant - Cho-A Pharm.Co.,Ltd. (688056831)

Establishment
Name	Address	ID/FEI	Business Operations
Cho-A Pharm.Co.,Ltd.		688056831	manufacture(58354-100)