FDA.reportPublic FDA data

Gelusil Tablets

Manufacturer
WellSpring Pharmaceutical Corporation
Effective date
2025-11-20
Label type
HUMAN OTC DRUG LABEL
Version
26
Source
full-release
Hydrated at
2026-06-01 01:17:18

Label at a glance#

ProductGelusil
Active ingredientALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE, UNSPECIFIED, SILICON DIOXIDE
Label structure9 sections

Indications and uses

Relieves: Heartburn Sour stomach Acid indigestion Bloating, pressure and discomfort commonly referred to as gas

Dosage and administration

Adults and children 12 years of age and older: Chew 2 to 4 tablets.  Repeat hourly if symptoms return, or as directed by a physician Children under 12 of age: ask a doctor Do not take more than 12 tablets in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician

Label contents#

Full prescribing information#

Active Ingredients (in each tablet)  

OTC - ACTIVE INGREDIENT SECTION

Aluminum hydroxide dried gel 200 mg
Magnesium hydroxide 200 mg
Simethicone 25 mg

Purpose

OTC - PURPOSE SECTION

Active ingredients (in each tablet)                  Purpose
Aluminum hydroxide dried gel 200 mg........................Antacid
Magnesium hydroxide 200 mg....................................Antacid
Simethicone 25 mg......................................................Antigas

Uses

INDICATIONS & USAGE SECTION

Relieves:

  • Heartburn
  • Sour stomach
  • Acid indigestion
  • Bloating, pressure and discomfort commonly referred to as gas

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • Kidney disease
  • A magnesium restricted diet

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

now taking a prescription drug.  Antacids may interact with certain prescription drugs.

Stop use and ask a doctor if

OTC - STOP USE SECTION

symptoms last more than 2 weeks

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away 1.800.222.1222

If pregnant or breastfeeding

SPL UNCLASSIFIED SECTION

 ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years of age and older:Chew 2 to 4 tablets.  Repeat hourly if symptoms return, or as directed by a physician
  • Children under 12 of age:ask a doctor
  • Do not take more than 12 tablets in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician

Other information

SPL UNCLASSIFIED SECTION

  • Each tablet contains: magnesium 95 mg
  • Store below 30°C (86°F)
  • Tamper Evident. Do not use if blister or printed Gelusil foil seal is broken
  • See end panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

Dextrose, flavors, magnesium stearate, maltodextrin, microcrystalline cellulose, silica, sucralose

Questions?

OTC - QUESTIONS SECTION

Call 1-844-241-5454

© WellSpring 2018

Sarasota, FL 34243 USA

Made in USA

Principal display panel - Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

  Gelusil Antacid Antigas 10 BlistersGelusil Antacid Antigas 10 Blisters

Gelusil Antacid 100 Chewable Tablets

SPL UNCLASSIFIED SECTION

Gelusil Antacid Antigas Cool mint 100 Chewable Tablets
Gelusil Antacid Antigas Cool mint 100 Chewable Tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307747aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 25 MG Chewable TabletPSN26
211633Gelusil Antacid & Anti-Gas 200 MG / 200 MG / 25 MG Chewable TabletPSN26
211633aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 25 MG Chewable Tablet [Gelusil]SBD26
307747aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 25 MG Chewable TabletSCD26
307747aluminum hydroxide 200 MG / milk of magnesia 200 MG / simethicone 25 MG Chewable TabSY26
211633Gelusil (aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 25 MG) Chewable TabletSY26
211633Gelusil Antacid & Anti-Gas (aluminum hydroxide 200 MG / milk of magnesia 200 MG / simethicone 25 MG) Chewable TabletSY26

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
MAGNESIUM CATION Pharmacologic Class Indexing4Indexing - 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65197-300-10Gelusil10 in 1 BLISTER PACKTABLET, CHEWABLE1026
65197-300-10Gelusil10 in 1 CARTONTABLET, CHEWABLE1026
65197-300-11Gelusil100 in 1 BOTTLETABLET, CHEWABLE10026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65197-300-10EA - Each65197-3008e370643-937c-4fe1-95c4-c2ce1d50c13012012-07-24
65197-300-11EA - Each65197-300bdc6445f-2da5-4c62-8ddd-a4e3be901ec912020-06-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALUMINUM HYDROXIDEACTIVE INGREDIENT5QB0T2IUN010
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1O10
MAGNESIUM HYDROXIDEACTIVE INGREDIENTNBZ3QY004S10
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU410
ALUMINUM HYDROXIDEACTIVE MOIETY5QB0T2IUN010
DIMETHICONEACTIVE MOIETY92RU3N3Y1O10
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY83810
SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU410
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I3010
MANNITOLINACTIVE INGREDIENT3OWL53L36A10
RAW SUGARINACTIVE INGREDIENT8M707QY5GH10
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY10
SORBITOLINACTIVE INGREDIENT506T60A25R10

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65197-30065197-300-10, 65197-300-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
SUCRALOSE96K6UQ3ZD4IACT
SILICONZ4152N8IUIIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
ALUMINUM HYDROXIDE5QB0T2IUN0ACTIB
MAGNESIUM HYDROXIDENBZ3QY004SACTIB
DIMETHICONE, UNSPECIFIED92RU3N3Y1OACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 12 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SORBITOLSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, CHEWABLE / ORAL3726 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, CHEWABLE / ORAL3726 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, CHEWABLE / ORAL84 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, CHEWABLE / ORAL3726 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, CHEWABLE / ORAL84 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, CHEWABLE / ORAL84 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates

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
GelusilALUMINA, MAGNESIA, SIMETHICONEWellSpring Pharmaceutical Corporation92fbeec1-1562-40f3-9734-41f133d494f92025-11-20WarningsExact identifier
ndc (package): 65197-300-11
ndc (package): 65197-300-10
ndc (product): 65197-300
ndc11 (package): 65197030011
ndc11 (package): 65197030010
spl id: 4406bf6b-b261-c6e1-e063-6294a90ae101
spl set id: 92fbeec1-1562-40f3-9734-41f133d494f9

Reported adverse events (FAERS/openFDA)#

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