FDA.reportPublic FDA data

Antacid

Manufacturer
Safeway | Guardian Drug Company
Effective date
2016-01-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:44:42

Label at a glance#

ProductAntacid
Active ingredientALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE
Label structure8 sections

Indications and uses

relieves: acid indigestion heartburn sour stomach upset stomach and gas associated with these symptoms

Dosage and administration

shake well before use. adults and children 12 years and older: take 2 to 4 teaspoonfuls two times a day, or as directed by a doctor children under 12 years: consult a doctor

Storage and handling

each teaspoon contains: magnesium 170 mg, sodium 5 mg store at controlled room temperature 20 o C-25 o C (68 o F-77 o F) do not freeze

Label contents#

Full prescribing information#

Active ingredient (in each 5mL tsp.)

OTC - ACTIVE INGREDIENT SECTION

Aluminum hydroxide (equvi. to dried gel, USP) 400 mg

Magnesium hydroxide 400 mg

Simethicone 40 mg

Purpose

OTC - PURPOSE SECTION

Antacid

Antacid

Antigas

Uses

INDICATIONS & USAGE SECTION

  • relieves:
  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach and gas associated with these symptoms

Warnings

WARNINGS SECTION

Do not take more than 8 teaspoonfuls in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

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

  • presently taking a prescription drug. Antacids may interact with certain prescription drugs.
Stop use and ask a doctor

OTC - STOP USE SECTION

if symptoms last more than two weeks

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before use.
  • adults and children 12 years and older: take 2 to 4 teaspoonfuls two times a day, or as directed by a doctor
  • children under 12 years: consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • each teaspoon contains: magnesium 170 mg, sodium 5 mg
  • store at controlled room temperature 20oC-25oC (68oF-77oF)
  • do not freeze

Inactive ingredients

INACTIVE INGREDIENT SECTION

flavor, glycerin, hydroxyethylcellulose, methylparaben, propylene glycol, purified water, saccharin sodium, simethicone emulsion, sorbitol

PDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Maalox maximum strength liquid cherry active ingredients

Maximum strength

Antacid Liquid

Aluminum Hydroxide 400 mg - Antacid

Magnesium Hydroxide 400 mg - Antacid

Simethicone 40 mg - Antigas

LBLLBL

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 SuspensionPSN1
237870aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML Oral SuspensionSCD1
237870aluminum hydroxide 2400 MG / magnesium hydroxide 2400 MG / dimethicone 240 MG per 30 ML Oral SuspensionSY1
237870aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG per 5 ML Oral SuspensionSY1
237870aluminum hydroxide 800 MG / magnesium hydroxide 800 MG / dimethicone 80 MG per 10 ML Oral SuspensionSY1

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
21130-508-05Antacid177 mL in 1 BOTTLESUSPENSION1771

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-508ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE AND SIMETHICONE) SUSPENSION [SAFEWAY]1Current NDC, Legacy NDC, 1 package rows20160122_d36b56a4-06f0-47ff-8add-4c327d60be22.zip

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
21130-50821130-508-05

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
ALUMINUM HYDROXIDE5QB0T2IUN0ACTIB
MAGNESIUM HYDROXIDENBZ3QY004SACTIB
DIMETHICONE92RU3N3Y1OACTIB
GLYCERINPDC6A3C0OXIACT
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)R33S7TK2EPIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT

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
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE AND SIMETHICONESafewayd36b56a4-06f0-47ff-8add-4c327d60be222016-01-21WarningsExact identifier
ndc (package): 21130-508-05
ndc (product): 21130-508
ndc11 (package): 21130050805
spl id: ac703a32-8e0f-4dd4-b7b8-5fba72b7cd59
spl set id: d36b56a4-06f0-47ff-8add-4c327d60be22

Reported adverse events (FAERS/openFDA)#

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