Maalox Antacid

Manufacturer
Physicians Total Care, Inc.
Effective date
2012-01-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:30:49

Label at a glance#

ProductMaalox Antacid
Active ingredientALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE
Label structure9 sections

Indications and uses

for the relief of acid indigestion heartburn sour stomach upset stomach associated with these symptoms pressure and bloating commonly referred to as gas

Dosage and administration

shake well before using adults and children 12 years and older: take 2-4 tsp (10-20 mL) up to 4 times a day or as directed by a doctor children under 12: ask a doctor

Storage and handling

each teaspoon contains: calcium 25 mg and magnesium 85 mg store at 20°-25°C (68°-77°F) does not meet USP requirements for preservative effectiveness

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL teaspoon)

OTC - ACTIVE INGREDIENT SECTION

Aluminum hydroxide (equiv. to dried gel, USP) 200 mg

Magnesium hydroxide 200 mg

Simethicone 20 mg

Purpose

OTC - PURPOSE SECTION

Antacid

Antigas

Uses

INDICATIONS & USAGE SECTION

for the relief of

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms
  • pressure and bloating 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.

When using this product

OTC - WHEN USING SECTION

do not exceed 16 teaspoonsful (80 mL) in a 24-hour period or use the maximum dosage for more than 2 weeks unless directed by a doctor

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before using
  • adults and children 12 years and older: take 2-4 tsp (10-20 mL) up to 4 times a day or as directed by a doctor
  • children under 12: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each teaspoon contains: calcium 25 mg and magnesium 85 mg
  • store at 20°-25°C (68°-77°F)
  • does not meet USP requirements for preservative effectiveness

Inactive ingredients

INACTIVE INGREDIENT SECTION

butylparaben, carboxymethylcellulose sodium, flavor, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Regular Strength

Liquid Antacid

Antacid & Anti-Gas

Fast Relief of:

Heartburn

Acid Indigestion

Sour Stomach & Upset Stomach

Mint Flavor

Maalox Antacid     12 fl oz (355 mL)

NDC 54868-2093-0

image of package label
image of package label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307746aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 20 MG in 5 mL Oral SuspensionPSN1
210031Maalox Advanced 200 MG / 200 MG / 20 MG in 5 mL Oral SuspensionPSN1
210031aluminum hydroxide 40 MG/ML / magnesium hydroxide 40 MG/ML / simethicone 4 MG/ML Oral Suspension [Maalox Plus]SBD1
307746aluminum hydroxide 40 MG/ML / magnesium hydroxide 40 MG/ML / simethicone 4 MG/ML Oral SuspensionSCD1
307746aluminum hydroxide 1200 MG / milk of magnesia 1200 MG / dimethicone 120 MG per 30 ML Oral SuspensionSY1
307746aluminum hydroxide 200 MG / milk of magnesia 200 MG / dimethicone 20 MG per 5 ML Oral SuspensionSY1
307746aluminum hydroxide 400 MG / milk of magnesia 400 MG / dimethicone 40 MG per 10 ML Oral SuspensionSY1
210031Maalox Advanced (aluminum hydroxide 200 MG / milk of magnesia 200 MG / simethicone 20 MG) per 5 ML Oral SuspensionSY1
210031Maalox Plus (aluminum hydroxide 40 MG / milk of magnesia 40 MG / simethicone 4 MG) per ML Oral SuspensionSY1

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54868-2093-02019-09-24C16284748780-19350213a-45c2-c013-e053-90daa90a1393e2a14762-3860-44c3-a3ea-5dbc45f4b1d5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54868-2093-0Maalox Antacid355 mL in 1 BOTTLELIQUID3551

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54868-2093MAALOX ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [PHYSICIANS TOTAL CARE, INC.]11 package rows20120130_e2a14762-3860-44c3-a3ea-5dbc45f4b1d5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0851-40ML - Milliliter0113-085172cf17a5-6617-4e96-aaaa-78673b22331412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALUMINUM HYDROXIDEACTIVE INGREDIENT5QB0T2IUN01
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1O1
MAGNESIUM HYDROXIDEACTIVE INGREDIENTNBZ3QY004S1
ALUMINUM HYDROXIDEACTIVE MOIETY5QB0T2IUN01
DIMETHICONEACTIVE MOIETY92RU3N3Y1O1
MAGNESIUM HYDROXIDEACTIVE MOIETYNBZ3QY004S1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV81
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS3111
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
SORBITOLINACTIVE INGREDIENT506T60A25R1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54868-209354868-2093-0
0113-0851

Ingredients#

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

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

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 6 · 309 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, SUSPENSION / INTRAVITREAL0.5 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPASTE / ORAL3 mgExact identifier — unii candidate
34 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / AURICULAR (OTIC)NAExact identifier — unii candidate
68 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET, CHEWABLE / ORAL24.75 mgExact identifier — unii candidate
44 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHDROPS / AURICULAR (OTIC)NAExact identifier — unii candidate
68 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRALESIONAL45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / OPHTHALMIC6 mgExact identifier — unii candidate
44 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLIQUID / ORAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / RECTAL46.18 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25REMULSION / TOPICAL7 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSUSPENSION / RECTAL290 mgExact identifier — unii candidate
34 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED, EXTENDED RELEASE / ORAL221 mgExact identifier — unii candidate
27 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION/ DROPS / OPHTHALMIC2 mgExact identifier — unii candidate
44 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / SOFT TISSUE0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / INTRAMUSCULAR6 mgExact identifier — unii candidate
68 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RGUM, CHEWING / BUCCAL5110 mgExact identifier — unii candidate
44 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET / ORAL43 mgExact identifier — unii candidate
34 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8CAPSULE, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
15 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHTABLET, CHEWABLE / ORAL0.14 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / TOPICAL24 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSPRAY / NASAL0.2 mgExact identifier — unii candidate
68 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOCAPSULE, COATED PELLETS / ORAL3.32 mgExact identifier — unii candidate
27 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSYSTEM / TOPICAL54 mgExact identifier — unii candidate
27 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL144 mgExact identifier — unii candidate
28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION, EXTENDED RELEASE / ORAL1120 mgExact identifier — unii candidate
28 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSYRUP / ORAL24 mgExact identifier — unii candidate
34 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED, EXTENDED RELEASE / ORAL615 mgExact identifier — unii candidate
28 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4FILM, EXTENDED RELEASE / TRANSDERMAL49 mgExact identifier — unii candidate
49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UGRANULE, FOR SUSPENSION / ORAL278 mgExact identifier — unii candidate
28 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311GEL / DENTAL0.4 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311POWDER, FOR SUSPENSION / INTRAMUSCULAR0.7 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / BUCCAL3 mgExact identifier — unii candidate
49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UGRANULE / ORAL29520 mgExact identifier — unii candidate
28 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRAMUSCULARNAExact identifier — unii candidate
44 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOCAPSULE / ORAL1488 mgExact identifier — unii candidate
27 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TAMPON / VAGINALNAExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4DROPS / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311FILM / BUCCAL18 mgExact identifier — unii candidate
44 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYFILM, SOLUBLE / BUCCAL2 mgExact identifier — unii candidate
34 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION/ DROPS / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSPRAY / TOPICAL0.8 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING / ORAL68 mgExact identifier — unii candidate
49 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHDROPS / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii candidate
44 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOLOTION / TOPICAL0.1 %w/wExact identifier — unii candidate
27 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8LIQUID / TOPICAL0.02 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET / BUCCAL4 mgExact identifier — unii candidate
44 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSOLUTION / ORAL665 mgExact identifier — unii candidate
34 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER, FOR SUSPENSION / ORAL12000 mgExact identifier — unii candidate
44 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / RESPIRATORY (INHALATION)0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET, DELAYED RELEASE / ORAL280 mgExact identifier — unii candidate
44 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSHAMPOO / TOPICAL0.03 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOINSERT / VAGINAL54.21 mgExact identifier — unii candidate
27 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHFILM, SOLUBLE / BUCCAL1 mgExact identifier — unii candidate
68 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOGRANULE / ORAL45 mgExact identifier — unii candidate
27 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SOLUTION / ORAL336 mgExact identifier — unii candidate
49 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCONCENTRATE / ORAL2.5 mg/5mlExact identifier — unii candidate
68 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, SUSPENSION / INTRALESIONAL15 mgExact identifier — unii candidate
44 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
27 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii candidate
28 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
d4312878-bdb9-4241-98e0-c77553ca4286e2a14762-3860-44c3-a3ea-5dbc45f4b1d52012-01-04WarningsExact identifier
spl id: d4312878-bdb9-4241-98e0-c77553ca4286
spl set id: e2a14762-3860-44c3-a3ea-5dbc45f4b1d5

Reported adverse events (FAERS/openFDA)#

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