GELFOS-M- aluminum phosphate, colloidal, magnesium hydroxide, simethicone liquid 
LYDIA 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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Aluminum Phosphate, Colloidal

Magnesium Hydroxide

Simethicone

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

Keep out of reach of children

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

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

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

For oral use only

1

GELFOS-M 
aluminum phosphate, colloidal, magnesium hydroxide, simethicone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72988-0017
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM PHOSPHATE (UNII: F92V3S521O) (ALUMINUM PHOSPHATE - UNII:F92V3S521O) ALUMINUM PHOSPHATE12.38 g  in 20 g
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE400 mg  in 20 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE40 mg  in 20 g
Inactive Ingredients
Ingredient NameStrength
PECTIN (UNII: 89NA02M4RX)  
WATER (UNII: 059QF0KO0R)  
AGAR (UNII: 89T13OHQ2B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72988-0017-14 in 1 PACKAGE10/08/2019
120 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33110/08/2019
Labeler - LYDIA Co., Ltd (695735569)
Registrant - LYDIA Co., Ltd (695735569)
Establishment
NameAddressID/FEIBusiness Operations
I World Pharmaceutical Co., Ltd688222857manufacture(72988-0017)
Establishment
NameAddressID/FEIBusiness Operations
LYDIA Co., Ltd695735569label(72988-0017)

Revised: 10/2019
Document Id: 94606cbd-191a-32f4-e053-2995a90a7447
Set id: 94606ac9-dc2e-4d32-e053-2995a90a5d6f
Version: 1
Effective Time: 20191008
 
LYDIA Co., Ltd