FDA.reportPublic FDA data

MAXIMUM STRENGTH ANTACID AND GASRELIEF

Manufacturer
GOODSENSE | GCP Laboratories
Effective date
2023-11-07
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:59:23

Label at a glance#

ProductMAXIMUM STRENGTH ANTACID AND GASRELIEF
Active ingredientALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE
Label structure9 sections

Indications and uses

relieves heartburn sour stomach acid indigestion the symptoms referred to as gas

Dosage and administration

shake well before use adults and children 12 years of age and older: take 10 mL to 20 mL (1 to 2 doses) between meals as needed, at bedtime, or as directed by a doctor children under 12 years of age: ask a doctor

Storage and handling

each 10 mL teaspoonful contains: magnesium 340 mg, sodium 10 mg do not freeze store at room temperature tightly closed

Label contents#

Full prescribing information#

Active ingredients (in each 10 mL dose)

OTC - ACTIVE INGREDIENT SECTION

Aluminum hydroxide 800 mg (equivalent to dried gel, USP)

Magnesium hydroxide 800 mg

Simethicone 80 mg

Purposes

OTC - PURPOSE SECTION

Antacid

Antigas

Uses

INDICATIONS & USAGE SECTION

relieves

  • heartburn
  • sour stomach
  • acid indigestion
  • the symptoms referred to as gas

Warnings

WARNINGS SECTION

Do not take more than 60 mL (6 doses) in a 24 hour period or use
the maximum dosage for more than 2 weeks.

Ask a doctor before use if you have

  • kidney disease
  • a magnesium-restricted diet

Ask a doctor or pharmacist before use if you are taking a prescription drug.

Antacids may interact with certain prescription drugs.

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before use
  • adults and children 12 years of age and older: take 10 mL to 20 mL (1 to 2 doses) between meals as needed, at bedtime, or as directed by a doctor
  • children under 12 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each 10 mL teaspoonful contains: magnesium 340 mg, sodium 10 mg
  • do not freeze
  • store at room temperature tightly closed

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, butylparaben, carboxymethylcellulose sodium, flavor (contains alcohol), hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

Questions or comments?

OTC - QUESTIONS SECTION

1-800-540-3765

package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
237870aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG in 5 mL Oral SuspensionPSN4
237870aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML Oral SuspensionSCD4
237870aluminum hydroxide 2400 MG / magnesium hydroxide 2400 MG / dimethicone 240 MG per 30 ML Oral SuspensionSY4
237870aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG per 5 ML Oral SuspensionSY4
237870aluminum hydroxide 800 MG / magnesium hydroxide 800 MG / dimethicone 80 MG per 10 ML Oral SuspensionSY4

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50804-619-12MAXIMUM STRENGTH ANTACID AND GASRELIEF355 mL in 1 BOTTLESUSPENSION3554

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50804-619MAXIMUM STRENGTH ANTACID AND GASRELIEF (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [GOODSENSE]4Current NDC, Legacy NDC, 1 package rows20231108_a9654a96-9bfd-60ea-e053-2995a90ae38d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-619-12ML - Milliliter50804-619f67593af-25a2-47c8-95ae-f4f7cee33c1512022-01-06

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50804-61950804-619-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZYL ALCOHOLLKG8494WBHIACT
BUTYLPARABEN3QPI1U3FV8IACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
HYPROMELLOSES3NXW29V3WOIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL SOLUTION8KW3E207O2IACT
ALUMINUM HYDROXIDE5QB0T2IUN0ACTIB
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
MAXIMUM STRENGTH ANTACID AND GASRELIEFALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGOODSENSEa9654a96-9bfd-60ea-e053-2995a90ae38d2023-11-07WarningsExact identifier
ndc (package): 50804-619-12
ndc (product): 50804-619
ndc11 (package): 50804061912
spl id: 0993d17e-73ca-48fd-e063-6294a90abc13
spl set id: a9654a96-9bfd-60ea-e053-2995a90ae38d

Reported adverse events (FAERS/openFDA)#

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