GELFOS-M- aluminum phosphate, colloidal, magnesium hydroxide, simethicone liquid

GELFOS-M by

Drug Labeling and Warnings

GELFOS-M by is a Otc medication manufactured, distributed, or labeled by OASIS TRADING. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Aluminum Phosphate, Colloidal

Magnesium Hydroxide

Simethicone

PURPOSE

■ sour stomach ■ acid indigestion ■ upset stomach associated with these

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

■ take 2-3 envelops as symptoms accur, as directed by a doctor

WARNINGS

Warnings

Ask a doctor before use if you have taking a prescription drug. Antacids may interact with certain prescription drugs

When using this product

■ Do not take more than 4 envelop in 24 hours

■ Do not use the maximum dosage for more than 2 weeks

INACTIVE INGREDIENT

water, sugar, agar, pectin, essence of orange, calcium

DOSAGE & ADMINISTRATION

For oral use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GELFOS-M 
aluminum phosphate, colloidal, magnesium hydroxide, simethicone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72689-0008
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM PHOSPHATE (UNII: F92V3S521O) (ALUMINUM PHOSPHATE - UNII:F92V3S521O)	ALUMINUM PHOSPHATE	12.38 g  in 20 g
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P)	MAGNESIUM HYDROXIDE	400 mg  in 20 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	40 mg  in 20 g

Inactive Ingredients
Ingredient Name	Strength
PECTIN (UNII: 89NA02M4RX)
WATER (UNII: 059QF0KO0R)
AGAR (UNII: 89T13OHQ2B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72689-0008-1	4 in 1 PACKAGE	11/15/2018
1		20 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	11/15/2018

Labeler - OASIS TRADING (689991468)

Registrant - OASIS TRADING (689991468)

Establishment
Name	Address	ID/FEI	Business Operations
OASIS TRADING		689991468	manufacture(72689-0008) , relabel(72689-0008)