Galeo: Package Insert and Label Information

GALEO- 4,4′-oxydi-2-butanol 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.

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
(click image for full-size original)

GALEO
dihydroxydibutylether liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58354-100
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
4,4′-OXYDI-2-BUTANOL (4,4′-OXYDI-2-BUTANOL) 4,4′-OXYDI-2-BUTANOL 5 g in 50 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM BENZOATE
ANHYDROUS CITRIC ACID
SORBITOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58354-100-02 1 BOTTLE in 1 PACKAGE contains a BOTTLE (58354-100-01)
1 NDC:58354-100-01 50 mL in 1 BOTTLE This package is contained within the PACKAGE (58354-100-02)
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 Operations
Cho-A Pharm.Co.,Ltd. 688056831 manufacture (58354-100)

Revised: 02/2017 Cho-A Pharm.Co.,Ltd.

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