GALEO- dihydroxydibutylether liquid 
Cho-A Pharm.Co.,Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Galeo

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

galeo label

GALEO 
dihydroxydibutylether liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58354-100
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
4,4'-OXYDI-2-BUTANOL (UNII: CR6X2Y7NRR) (4,4'-OXYDI-2-BUTANOL - UNII:CR6X2Y7NRR) 4,4'-OXYDI-2-BUTANOL5 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SORBITOL (UNII: 506T60A25R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58354-100-021 in 1 PACKAGE02/28/2017
1NDC:58354-100-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/28/2017
Labeler - Cho-A Pharm.Co.,Ltd. (688056831)
Registrant - Cho-A Pharm.Co.,Ltd. (688056831)
Establishment
NameAddressID/FEIBusiness Operations
Cho-A Pharm.Co.,Ltd.688056831manufacture(58354-100)

Revised: 2/2017
Document Id: 76daffb5-71ec-463f-aae0-c7920acef51d
Set id: be9d1f8c-f7b8-41fc-8c3f-d471dd6534c8
Version: 1
Effective Time: 20170216
 
Cho-A Pharm.Co.,Ltd.