Aluminum Hydroxide, Magnesium Hydroxide and Simethicone

Manufacturer
Rising Pharma Holdings, Inc.
Effective date
2025-07-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:06:24

Label at a glance#

ProductAluminum Hydroxide, Magnesium Hydroxide and Simethicone
Active ingredientALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE
Label structure9 sections

Dosage and administration

1,200-1,200-120 mg/30 mL •   Do not use more than 4 unit dose (120 mL) in a 24 hour period or use the maximum dose for more than 2 weeks  age dose Adults and children over 12 years of age Take 30 mL, one unit dose, between meals and at bedtime, or as directed by a doctor. Do not exceed 4 x 30 mL unit dose (120 mL) in a 24 hour period Children under 12 years of age Ask a doctor  2,400-2,400-240 mg/30 mL •   Do not ...

Storage and handling

1,200-1,200-120 mg/30 mL •    each 30 mL (unit dose) contains magnesium 510 mg and sodium 18 mg •   store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] •   protect from freezing •   do not use if lid is torn or broke 2,400-2,400-240 mg/30 mL •    each 30 mL (unit dose) contains magnesium 990 mg and sodium 6 mg •   store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] •   p...

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

1,200-1,200-120 mg/30 mL

Active ingredient per 30mL (1 Unit Dose)                                                                                                                                        
Aluminum hydroxide 1,200mg (equivalent to dried gel USP)
Magnesium hydroxide 1,200mg
Simethicone 120mg

2,400-2,400-240 mg/30 mL

Active ingredient per 30mL (1 Unit Dose)
Aluminum hydroxide 2,400mg (equivalent to dried gel USP)
Magnesium hydroxide 2,400mg
Simethicone 240mg

​Purpose

Antacid

Antigas

INDICATIONS & USAGE SECTION

Uses

relieves

• heartburn

• sour stomach

• acid indigestion

• the symptoms referred to as gas

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

• kidney disease

• a magnesium restricted diet

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Directions • shake well before use

DOSAGE & ADMINISTRATION SECTION

1,200-1,200-120 mg/30 mL

•   Do not use more than 4 unit dose (120 mL) in a 24 hour period or use the maximum dose for more than 2 weeks

 agedose
Adults and children over 12 years of ageTake 30 mL, one unit dose, between meals and at bedtime, or as directed by a doctor. Do not exceed 4 x 30 mL unit dose (120 mL) in a 24 hour period
Children under 12 years of ageAsk a doctor 

2,400-2,400-240 mg/30 mL

•   Do not use more than 2 unit dose (60 mL) in a 24 hour period or use the maximum dose for more than 2 weeks

 agedose
Adults and children over 12 years of ageTake 30 mL, one unit dose, one to two times daily or as directed by a doctor. Do not exceed 2 x 30 mL unit dose (60 mL) in a 24 hour period
Children under 12 years of ageAsk a doctor

Other information

STORAGE AND HANDLING SECTION

1,200-1,200-120 mg/30 mL

•   each 30 mL (unit dose) contains magnesium 510 mg and sodium 18 mg

•   store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]

•   protect from freezing

•   do not use if lid is torn or broke

2,400-2,400-240 mg/30 mL

•   each 30 mL (unit dose) contains magnesium 990 mg and sodium 6 mg

•   store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]

•   protect from freezing

•   do not use if lid is torn or broken

INACTIVE INGREDIENT SECTION

1,200-1,200-120 mg/30 mL / 2,400-2,400-240 mg/30 mL

Inactive ingredients benzyl alcohol, butylparaben, carboxy-methycellulose sodium, flavor, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

OTC - QUESTIONS SECTION

NDC Information -


1,200-1,200-120 mg/30 mL

Each 30 mL of Aluminium Hydroxide / Magensium Hydroxide / Simethicone contains Aluminum hydroxide 1,200 mg, Magnesium hydroxide 1,200 mg and Simethicone 120 mg and is supplied in the following oral dosage forms:

NDC 57237-316-03 unit dose cup 30 mL
NDC 57237-316-31 (100 x 30 mL) unit-dose cups


2,400-2,400-240 mg/30 mL

Each 30 mL of Aluminium Hydroxide / Magensium Hydroxide / Simethicone contains Aluminum hydroxide 2,400 mg, Magnesium hydroxide 2,400 mg and Simethicone 240 mg and is supplied in the following oral dosage forms:

NDC 57237-324-03 unit dose cup 30 mL
NDC 57237-324-31 (100 x 30 mL) unit-dose cups

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1,200-1,200-120 mg/30 mL

Case Label NDC 57237-316-31

Mag-Al-Case-Lab-01Mag-Al-Case-Lab-01

1,200-1,200-120 mg/30 mL

Lid Label NDC 57237-316-03

Mag-Al-Lid-Lab-01Mag-Al-Lid-Lab-01

2,400-2,400-240 mg/30 mL

Case Label NDC 57237-324-31

Mag-Al-Case-Lab-02Mag-Al-Case-Lab-02

2,400-2,400-240 mg/30 mL
Lid Label NDC 57237-324-03

Mag-Al-Lid-Lab-02Mag-Al-Lid-Lab-02

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 SuspensionPSN3
237870aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG in 5 mL Oral SuspensionPSN3
307746aluminum hydroxide 40 MG/ML / magnesium hydroxide 40 MG/ML / simethicone 4 MG/ML Oral SuspensionSCD3
237870aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML Oral SuspensionSCD3
307746aluminum hydroxide 1200 MG / milk of magnesia 1200 MG / dimethicone 120 MG per 30 ML Oral SuspensionSY3
307746aluminum hydroxide 200 MG / milk of magnesia 200 MG / dimethicone 20 MG per 5 ML Oral SuspensionSY3
237870aluminum hydroxide 2400 MG / magnesium hydroxide 2400 MG / dimethicone 240 MG per 30 ML Oral SuspensionSY3
237870aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG per 5 ML Oral SuspensionSY3
307746aluminum hydroxide 400 MG / milk of magnesia 400 MG / dimethicone 40 MG per 10 ML Oral SuspensionSY3
237870aluminum hydroxide 800 MG / magnesium hydroxide 800 MG / dimethicone 80 MG per 10 ML Oral SuspensionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - 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
57237-316-03Aluminum Hydroxide, Magnesium Hydroxide and Simethicone30 mL in 1 CUP, UNIT-DOSESUSPENSION303
57237-316-31Aluminum Hydroxide, Magnesium Hydroxide and Simethicone100 in 1 BOX, UNIT-DOSESUSPENSION1003
57237-324-03Aluminum Hydroxide, Magnesium Hydroxide and Simethicone30 mL in 1 CUP, UNIT-DOSESUSPENSION303
57237-324-31Aluminum Hydroxide, Magnesium Hydroxide and Simethicone100 in 1 BOX, UNIT-DOSESUSPENSION1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-316-03ML - Milliliter57237-3168d8f9c7b-c4d9-42ba-94c4-161057268f0412023-09-05
57237-316-31ML - Milliliter57237-3163cab9d8d-c9b9-4017-9d23-a14f66fe386912023-09-05
57237-324-03ML - Milliliter57237-32467148dfe-350b-4a69-8720-f8be5415fb4012023-10-16
57237-324-31ML - Milliliter57237-324c1967d33-659d-4a98-8698-0a7cea113f7412023-10-16

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57237-31657237-316-03, 57237-316-31
57237-32457237-324-03, 57237-324-31

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

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
Aluminum Hydroxide, Magnesium Hydroxide and SimethiconeALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONERising Pharma Holdings, Inc.982129d4-3cbf-4793-a861-d6c8f34bedc32025-07-01WarningsExact identifier
ndc (package): 57237-316-31
ndc (package): 57237-324-31
ndc (package): 57237-316-03
ndc (package): 57237-324-03
ndc (product): 57237-324
ndc (product): 57237-316
ndc11 (package): 57237031631
ndc11 (package): 57237032431
ndc11 (package): 57237032403
ndc11 (package): 57237031603
spl id: ea8b3419-ff01-4c21-9308-74ff70433ca0
spl set id: 982129d4-3cbf-4793-a861-d6c8f34bedc3

Reported adverse events (FAERS/openFDA)#

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