Topcare Antacid

Manufacturer: Topco Associates LLC
Effective date: 2022-02-22
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: legacy-cache
Hydrated at: 2026-08-01 22:08:15

Label at a glance#

ProductTopcare 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 • only use the dose cup provided • adults and children 12 years and older: take 10 mL to 20 mL four times a day or as directed by a physician • do not take more than 80 mL in 24 hours or use the maximum dosage for more than 2 weeks • children under 12 years: consult a physician

Storage and handling

• each 10 mL contains: magnesium 175 mg • does not meet USP requirements for preservative effectiveness • store at 20-25ºC (68-77ºF) • protect from freezing

Contacts and useful links#

PhoneLabel contact1-888-423-0139

Label contents#

Full prescribing information#

Active ingredients (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

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

Magnesium hydroxide 400 mg

Simethicone 40 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

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

When using this product

OTC - WHEN USING SECTION

do not take more than 80 mL in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

shake well before using
only use the dose cup provided
adults and children 12 years and older: take 10 mL to 20 mL four times a day or as directed by a physician
do not take more than 80 mL in 24 hours or use the maximum dosage for more than 2 weeks
children under 12 years: consult a physician

Other information

STORAGE AND HANDLING SECTION

each 10 mL contains: magnesium 175 mg
does not meet USP requirements for preservative effectiveness
store at 20-25ºC (68-77ºF)
protect from freezing

Inactive ingredients

INACTIVE INGREDIENT SECTION

butylparaben, flavor, hypromellose, microcrystalline cellulose and carboxymethylcellulose sodium, peppermint oil, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol, sorbitol solution

Questions or comments?

OTC - QUESTIONS SECTION

1-888-423-0139

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

REGULAR STRENGTH

Antacid Advanced

ANTACID & ANTIGAS

OUR PHARMACISTS RECOMMEND

FAST RELIEF

Heartburn

Acid Indigestion

Pressure

Bloating (Gas)

12 FL OZ (355 mL)

MINT FLAVOR

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
36800-851-40	ML - Milliliter	36800-851	6046900a-1266-4aa4-aec6-d70834e1da82	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ALUMINUM HYDROXIDE	ACTIVE INGREDIENT	5QB0T2IUN0	2
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	2
MAGNESIUM HYDROXIDE	ACTIVE INGREDIENT	NBZ3QY004S	2
ALUMINUM HYDROXIDE	ACTIVE MOIETY	5QB0T2IUN0	2
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	2
HYDROXIDE ION	ACTIVE MOIETY	9159UV381P	2
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	2
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	2
PEPPERMINT OIL	INACTIVE INGREDIENT	AV092KU4JH	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

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

Topcare Antacid
Aluminum hydroxide, Magnesium hydroxide, Simethicone
ALUMINUM HYDROXIDE
MAGNESIUM HYDROXIDE
MAGNESIUM CATION
HYDROXIDE ION
DIMETHICONE
BUTYLPARABEN
HYPROMELLOSE, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
PEPPERMINT OIL
PROPYLPARABEN
WATER
SACCHARIN SODIUM
SORBITOL
SILICON DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
36800-851	36800-851-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALUMINUM HYDROXIDE	5QB0T2IUN0	ACTIB
MAGNESIUM HYDROXIDE	NBZ3QY004S	ACTIB
DIMETHICONE	92RU3N3Y1O	ACTIB
BUTYLPARABEN	3QPI1U3FV8	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	K679OBS311	IACT
PEPPERMINT OIL	AV092KU4JH	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
WATER	059QF0KO0R	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SORBITOL	506T60A25R	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT

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 · 330 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	LOTION / TOPICAL		4 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, EXTENDED RELEASE / ORAL	0.12 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TROCHE / ORAL		300 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	TABLET, ORALLY DISINTEGRATING / ORAL		3 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	PASTE, DENTIFRICE / DENTAL	1.2 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / ORAL		602 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	ELIXIR / ORAL	0.04 mg/1ml		Exact identifier — unii candidate 21 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRAMUSCULAR	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, DELAYED RELEASE / ORAL		2210 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE / ORAL		254 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	OINTMENT / TOPICAL	0.18 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SOLUTION / ORAL		280 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, CHEWABLE / ORAL		84 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	INJECTION / INTRAMUSCULAR		22 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	CAPSULE / ORAL	160 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CREAM / VAGINAL		51 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	CAPSULE / ORAL		60 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	TABLET, EXTENDED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SOLUTION / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / RECTAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	FILM, SOLUBLE / BUCCAL		47 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM / TOPICAL		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION / INTRASYNOVIAL	0.1 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SUSPENSION / ORAL		1080 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / DENTAL	0.05 %w/v		Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	ELIXIR / ORAL	15 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, EXTENDED RELEASE / ORAL		450 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	SOLUTION / RECTAL	0.01 %w/v		Exact identifier — unii candidate 15 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	CAPSULE, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 15 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, DELAYED RELEASE / ORAL		105 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CONCENTRATE / ORAL	600 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET / ORAL	0.2 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE / ORAL		1725 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	CAPSULE, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAVENOUS		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	POWDER, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	AEROSOL, FOAM / VAGINAL	0.2 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR		25 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	AEROSOL, FOAM / TOPICAL	4.95 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PELLET / ORAL		34 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SYSTEM / TOPICAL		6300 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAMUSCULAR		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	LOTION / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LIQUID / ORAL		53460 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	POWDER, FOR SUSPENSION / INTRAMUSCULAR	0.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / NASAL	140 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	TABLET / ORAL	NA		Exact identifier — unii candidate 15 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	SUSPENSION / ORAL	100 mg/1ml		Exact identifier — unii candidate 21 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SOLUTION/ DROPS / OPHTHALMIC		2 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	EMULSION / TOPICAL	7 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, COATED / ORAL		58 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	CAPSULE / ORAL	NA		Exact identifier — unii candidate 15 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
92a9444e-fdaf-4c4b-b952-27ad442c8a4b			ee2d2f35-66af-4e8d-9494-dbb20cb134b6	2022-02-22	Warnings	Exact identifier spl id: 92a9444e-fdaf-4c4b-b952-27ad442c8a4b spl set id: ee2d2f35-66af-4e8d-9494-dbb20cb134b6

Reported adverse events (FAERS/openFDA)#

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