FDA.reportPublic FDA data

GELFOS-M

Manufacturer
LYDIA Co., Ltd | I World Pharmaceutical Co., Ltd
Effective date
2019-10-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:00:45

Label at a glance#

ProductGELFOS-M
Active ingredientALUMINUM PHOSPHATE, MAGNESIUM HYDROXIDE, DIMETHICONE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Aluminum Phosphate, Colloidal

Magnesium Hydroxide

Simethicone

OTC - PURPOSE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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 SECTION

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

DOSAGE & ADMINISTRATION SECTION

For oral use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72988-0017-12021-01-29C16284748780-1ba0f9c33-14d0-a910-e053-dadaa90a0b8594606ac9-dc2e-4d32-e053-2995a90a5d6f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72988-0017-1GELFOS-M4 in 1 PACKAGELIQUID41
72988-0017-1GELFOS-M20 g in 1 POUCHLIQUID201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72988-0017GELFOS-M (ALUMINUM PHOSPHATE, COLLOIDAL, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [LYDIA CO., LTD]1Legacy NDC, 2 package rows20191008_94606ac9-dc2e-4d32-e053-2995a90a5d6f.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72988-001772988-0017-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
PECTIN89NA02M4RXIACT
WATER059QF0KO0RIACT
AGAR89T13OHQ2BIACT
ALUMINUM PHOSPHATEF92V3S521OACTIB
MAGNESIUM HYDROXIDENBZ3QY004SACTIB
DIMETHICONE92RU3N3Y1OACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
94606cbd-191a-32f4-e053-2995a90a744794606ac9-dc2e-4d32-e053-2995a90a5d6f2019-10-08WarningsExact identifier
spl id: 94606cbd-191a-32f4-e053-2995a90a7447
spl set id: 94606ac9-dc2e-4d32-e053-2995a90a5d6f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.