GELFOS M- aluminum phosphate gel
Boryung Pharmaceutical Co., Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Aluminium phosphate 61.9%, Magnesium hydroxide 2.0%, Simethicone 0.2%

Water, Methylparaben, Propylparaben, etc

antacid

keep out of reach of the children

Relief the symptom of hypergastric acidity (including gastritis and gastroduodenal ulcer disease), heartburn, gastric discomfort, gastric fullness, nausea, vomiting, crapulence, gastric pain, belching up a bit of sour vomit, constipation protection and degassing.

Don't place the product in any place where it will be subjected to extremely high or low temperatures or direct sunlight.

Take 1 sachet orally, 3 times daily between each meal(at the mealtime and between each meal), 4 hours between dosage.

label

GELFOS M
aluminium phosphate, magnesium hydroxide, simethicone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64644-4002
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALUMINUM PHOSPHATE (UNII: F92V3S521O) (ALUMINUM PHOSPHATE - UNII:F92V3S521O)	ALUMINUM PHOSPHATE	61.9 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64644-4002-1	20 g in 1 POUCH; Type 0: Not a Combination Product	04/08/2016	04/11/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part331	02/28/2016	04/11/2016

Labeler - Boryung Pharmaceutical Co., Ltd (631099624)

Registrant - Boryung Pharmaceutical Co., Ltd (631099624)

Name	Address	ID/FEI	Business Operations
Establishment
Boryung Pharmaceutical Co., Ltd		631099624	manufacture(64644-4002)

Revised: 4/2016

Document Id: 30433130-f958-73ba-e054-00144ff8d46c

Set id: 2cde4d56-8685-499b-e054-00144ff8d46c

Version: 3

Effective Time: 20160412

Boryung Pharmaceutical Co., Ltd