MINTOX MAXIMUM STRENGTH

Manufacturer: ATLANTIC BIOLOGICALS CORP.
Effective date: 2025-07-31
Label type: HUMAN OTC DRUG LABEL
Version: 9
Source: full-release
Hydrated at: 2026-06-01 01:09:04

Label at a glance#

ProductMINTOX MAXIMUM STRENGTH

Active ingredientALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE

Label structure8 sections

Indications and uses

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

Dosage and administration

• shake well before use • do not take more than 8 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks • 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: ask a doctor

Storage and handling

• magnesium 165 mg, sodium 1 mg each 5 mL teaspoonful contains: • store at room temperature • protect from freezing • keep tightly closed • TAMPER-EVIDENT: Do not use if breakaway band on bottle cap is missing or broken.

Label contents#

Full prescribing information#

Active ingredients (in each 5 mL teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Aluminum hydroxide 400 mg (equivalent to dried gel, USP)

Magnesium hydroxide 400 mg

Simethicone 40mg

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

Ask a doctor before use if you have

• kidney disease

• a magnesium-restricted diet

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

Antacids may interact with certain prescription drugs.

symptoms last more than 2 weeks Stop use and ask a doctor if

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

• shake well before use

• do not take more than 8 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks

• 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: ask a doctor

Other information

STORAGE AND HANDLING SECTION

• magnesium 165 mg, sodium 1 mg each 5 mL teaspoonful contains:

• store at room temperature

• protect from freezing

• keep tightly closed

• TAMPER-EVIDENT: Do not use if breakaway band on bottle cap is missing or broken.

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, butylparaben, caramel color, carboxymethylcellulose sodium, D and C yellow no.10, flavor, glycerin, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

MINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
237870	aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG in 5 mL Oral Suspension	PSN	9
708127	Mintox Maximum Strength 400 MG / 400 MG / 40 MG in 5 mL Oral Suspension	PSN	9
708127	aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML Oral Suspension [Mintox Plus]	SBD	9
237870	aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML Oral Suspension	SCD	9
237870	aluminum hydroxide 2400 MG / magnesium hydroxide 2400 MG / dimethicone 240 MG per 30 ML Oral Suspension	SY	9
237870	aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG per 5 ML Oral Suspension	SY	9
237870	aluminum hydroxide 800 MG / magnesium hydroxide 800 MG / dimethicone 80 MG per 10 ML Oral Suspension	SY	9
708127	Mintox (aluminum hydroxide 400 MG / milk of magnesia 400 MG / simethicone 40 MG) per 5 ML Oral Suspension	SY	9
708127	Mintox Maximum Strength (aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML) Oral Suspension	SY	9

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIMETHICONE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6e3c022f-0786-43f1-8857-edff89d5153f	Product name	1	20260309
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
efd58652-cb8f-4018-91ca-4b0eb2ff729f	Product name	7	20240226
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62	Product name	3	20210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
e7e58cd3-cacb-49df-8d34-1ee335614abb	Product name	1	20150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17856-5725-1	2024-07-30	C162847	48780-1	f386c64a-0ff2-0266-e053-dadaa90a7c1a	Mintox Max
17856-5725-3	2024-07-30	C162847	48780-1	f386c64a-0ff2-0266-e053-dadaa90a7c1a	Mintox Max
17856-5725-1	2023-01-30	C162847	48780-1	f386c64a-0ff2-0266-e053-dadaa90a7c1a	Mintox Max
17856-5725-3	2023-01-30	C162847	48780-1	f386c64a-0ff2-0266-e053-dadaa90a7c1a	Mintox Max

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17856-5725-1	MINTOX MAXIMUM STRENGTH	15 mL in 1 CUP	SUSPENSION	15		9
17856-5725-3	MINTOX MAXIMUM STRENGTH	30 mL in 1 CUP	SUSPENSION	30		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17856-5725-3	ML - Milliliter	17856-5725	450f9c1d-edc9-4c3f-91ab-6b5580bf91bc	1	2014-09-03
0904-5725-14	ML - Milliliter	0904-5725	bdefd943-80db-4a30-a73c-f839d6f87baf	1	2013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ALUMINUM HYDROXIDE	ACTIVE INGREDIENT	5QB0T2IUN0	3
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	3
MAGNESIUM HYDROXIDE	ACTIVE INGREDIENT	NBZ3QY004S	3
ALUMINUM HYDROXIDE	ACTIVE MOIETY	5QB0T2IUN0	3
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	3
HYDROXIDE ION	ACTIVE MOIETY	9159UV381P	3
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	3
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	3
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	3
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

MINTOX MAXIMUM STRENGTH
aluminum hydroxide, magnesium hydroxide, dimethicone
BUTYLPARABEN
CARBOXYMETHYLCELLULOSE SODIUM
HYPROMELLOSES
CELLULOSE, MICROCRYSTALLINE
BENZYL ALCOHOL
PROPYLPARABEN
WATER
SACCHARIN SODIUM
SORBITOL
D&C YELLOW NO. 10
GLYCERIN
ALUMINUM HYDROXIDE
MAGNESIUM HYDROXIDE
MAGNESIUM CATION
HYDROXIDE ION
DIMETHICONE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
17856-5725	17856-5725-1, 17856-5725-3
0904-5725

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BUTYLPARABEN	3QPI1U3FV8	IACT
CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
WATER	059QF0KO0R	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SORBITOL	506T60A25R	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
GLYCERIN	PDC6A3C0OX	IACT
ALUMINUM HYDROXIDE	5QB0T2IUN0	ACTIB
MAGNESIUM HYDROXIDE	NBZ3QY004S	ACTIB
DIMETHICONE	92RU3N3Y1O	ACTIB

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 1 · 40 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SUSPENSION / ORAL		1080 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SUSPENSION / ORAL		100 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / ORAL		64 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SUSPENSION / ORAL		100 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SUSPENSION / ORAL		45000 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / ORAL		64 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SUSPENSION / ORAL		45000 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SUSPENSION / ORAL		100 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	SUSPENSION / ORAL		12 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	SUSPENSION / ORAL		12 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	SUSPENSION / ORAL		1600 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SUSPENSION / ORAL		1080 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / ORAL	5000 mg/5ml		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SUSPENSION / ORAL		1080 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SUSPENSION / ORAL		305 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	SUSPENSION / ORAL		1600 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	SUSPENSION / ORAL		1600 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / ORAL	5000 mg/5ml		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SUSPENSION / ORAL		305 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SUSPENSION / ORAL	20 mg/5ml		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	SUSPENSION / ORAL		12 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / ORAL		64 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SUSPENSION / ORAL		45000 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / ORAL	5000 mg/5ml		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	SUSPENSION / ORAL		1600 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / ORAL	5000 mg/5ml		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SUSPENSION / ORAL	20 mg/5ml		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SUSPENSION / ORAL	20 mg/5ml		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SUSPENSION / ORAL		305 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SUSPENSION / ORAL	20 mg/5ml		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SUSPENSION / ORAL		100 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	SUSPENSION / ORAL		12 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SUSPENSION / ORAL		45000 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / ORAL		64 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SUSPENSION / ORAL		305 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SUSPENSION / ORAL		1080 mg	Exact identifier — unii+route+dosage form 4 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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MINTOX MAXIMUM STRENGTH	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE	ATLANTIC BIOLOGICALS CORP.	ac6a47e7-972f-4b82-96da-89926d345e9f	2025-07-31	Warnings	Exact identifier ndc (package): 17856-5725-3 ndc (package): 17856-5725-1 ndc (product): 17856-5725 ndc11 (package): 17856572503 ndc11 (package): 17856572501 spl id: 3b3f429e-d2e4-441c-e063-6294a90aaf4d spl set id: ac6a47e7-972f-4b82-96da-89926d345e9f
MINTOX MAXIMUM STRENGTH	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE	MAJOR Pharmaceuticals Inc.	536b143d-a1d7-4972-a90b-248e41937070	2023-11-02	Warnings	Exact identifier ndc (product): 0904-5725

Reported adverse events (FAERS/openFDA)#

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