FDA.reportPublic FDA data

Antacid

Manufacturer
Retail Business Services, LLC. | Guardian Drug Company
Effective date
2024-12-11
Label type
Human OTC Drug Label
Version
2
Source
full-release
Hydrated at
2026-06-01 00:42:35

Label at a glance#

ProductAntacid
Active ingredientALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE
Label structure12 sections

Dosage and administration

shake well before use adults and children 12 years and older: take 10 - 20 mL two times a day, or as directed by a doctor children under 12 years: consult a doctor mL = milliliter

Storage and handling

each 10 mL contains: magnesium 340 mg, sodium 5 mg store at controlled room temperature 20ºC-25ºC (68º-77ºF) do not freeze

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (in each 10 mL )

OTC - ACTIVE INGREDIENT SECTION

Aluminum hydroxide (equiv. to dried gel, USP) 800 mg
Magnesium hydroxide 800 mg
Simethicone 80 mg

PURPOSE

OTC - PURPOSE SECTION

Antacid
Antacid
Antigas

USE(S)

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 60 mL 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 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 10 - 20 mL two times a day, or as directed by a doctor
  • children under 12 years: consult a doctor
  • mL = milliliter

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • each 10 mL contains: magnesium 340 mg, sodium 5 mg
  • store at controlled room temperature 20ºC-25ºC (68º-77ºF)
  • do not freeze

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

ethyl alcohol, flavor, glycerin, hydroxyethyl cellulose, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CAREONE
NDC 72476-516-05

Compare to the active ingredients in Mylanta® Maximum Strength

MAXIMUM STRENGTH

ANTACID LIQUID

Aluminum Hydroxide 800mg

Magnesium Hydroxide 800mg

Simethicone 80mg

Original Flavor

Relieves: 

Acid Indigestion, Pressure & Bloating (Gas)

12 FL OZ (355 mL)Alcohol content 0.2% v/v 

7979

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 SuspensionPSN2
237870aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML Oral SuspensionSCD2
237870aluminum hydroxide 2400 MG / magnesium hydroxide 2400 MG / dimethicone 240 MG per 30 ML Oral SuspensionSY2
237870aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG per 5 ML Oral SuspensionSY2
237870aluminum hydroxide 800 MG / magnesium hydroxide 800 MG / dimethicone 80 MG per 10 ML Oral SuspensionSY2

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
72476-516-05Antacid355 mL in 1 BOTTLELIQUID3552

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72476-516ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [RETAIL BUSINESS SERVICES, LLC.]2Current NDC, Legacy NDC, 1 package rows20241213_ce2edc57-e550-4aa9-bbfe-37933913c9eb.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72476-51672476-516-05

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
ALUMINUM HYDROXIDE5QB0T2IUN0ACTIB
MAGNESIUM HYDROXIDENBZ3QY004SACTIB
DIMETHICONE92RU3N3Y1OACTIB
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
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, SIMETHICONERetail Business Services, LLC.ce2edc57-e550-4aa9-bbfe-37933913c9eb2024-12-11WarningsExact identifier
ndc (package): 72476-516-05
ndc (product): 72476-516
ndc11 (package): 72476051605
spl id: da456848-d97d-4b41-9e55-f4ae189d3a36
spl set id: ce2edc57-e550-4aa9-bbfe-37933913c9eb

Reported adverse events (FAERS/openFDA)#

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