FDA.reportPublic FDA data

Magnesium Hydroxide, Aluminum Hydroxide, and Simethicone Suspension

Manufacturer
American Health Packaging
Effective date
2025-05-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:01:55

Label at a glance#

ProductAluminum Hydroxide, Magnesium Hydroxide, and Simethicone
Active ingredientALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE, UNSPECIFIED
Label structure11 sections

Indications and uses

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

Dosage and administration

shake well before using do not take more than 4 unit dose cups (120 mL) in 24 hours or use the maximum dosage for more than 2 weeks adults and children 12 years and older Take 30 mL, one unit dose cup, between meals and at bedtime, or as directed by a doctor. children under 12 years consult a physician

Storage and handling

each 30 mL contains: magnesium 498 mg, sodium 8.04 mg Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature]. protect from freezing White colored, peppermint flavored liquid supplied in the following oral dosage form: 30 mL unit dose cups: 100 cups (10 x 10) NDC 60687‐877‐76

Label contents#

Full prescribing information#

Active ingredients(in each 30 mL cup)

OTC - ACTIVE INGREDIENT SECTION

Aluminum hydroxide (equiv. to dried gel, USP) 1200 mg

Antacid

Magnesium hydroxide 1200 mg

Antacid

Simethicone 120 mg

Antigas

Purpose

OTC - PURPOSE SECTION

Antacid/Antigas

Uses

INDICATIONS & USAGE SECTION

for the relief of:

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach due to these symptoms
  • pressure and bloating commonly referred to as gas

Warnings

WARNINGS SECTION

Do not take more than 4 unit dose cups (120 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.

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 a doctor if

OTC - STOP USE SECTION

symptoms last more than 2 weeks.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before using
  • do not take more than 4 unit dose cups (120 mL) in 24 hours or use the maximum dosage for more than 2 weeks

adults and children 12 years and older

Take 30 mL, one unit dose cup, between meals and at bedtime, or as directed by a doctor.

children under 12 years

consult a physician

Other information

STORAGE AND HANDLING SECTION

  • each 30 mL contains: magnesium 498 mg, sodium 8.04 mg
  • Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature].
  • protect from freezing
  • White colored, peppermint flavored liquid supplied in the following oral dosage form:
  • 30 mL unit dose cups: 100 cups (10 x 10) NDC 60687‐877‐76

Inactive ingredients

INACTIVE INGREDIENT SECTION

Butylparaben, hydroxypropyl methylcellulose, flavoring, propylene glycol, propylparaben, purified water, saccharin sodium , and sorbitol solution.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-845-8210

DO NOT USE IF SEAL IS BROKEN.

Distributed by:

SPL UNCLASSIFIED SECTION

American Health Packaging
Columbus, OH 43217

R01/25

Principal Display Panel – Tray Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1200 mg 1200 mg 120 mg per 30 mL Mag Alu Sim Suspension Tray Label.jpg1200 mg 1200 mg 120 mg per 30 mL Mag Alu Sim Suspension Tray Label.jpg

Case NDC 60687-877-76/Cup NDC 60687-877-45

Magnesium Hydroxide,
Aluminum Hydroxide, and
Simethicone Suspension
Antacid/Antigas

1200 mg/1200 mg/120 mg per 30 mL

Sugar Free

SHAKE WELL

USUAL DOSAGE: See attached Drug Facts

Store at 20° to 25°C (68° to 77°F)
[See USP Controlled Room Temperature].
Protect from freezing.

For Institutional Use Only

T1761C300125            R01/25

Principal Display Panel – Cup – 1200 mg/1200 mg/120 mg 30 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1200 mg 1200 mg 120 mg per 30 mL Mag Alu Sim Suspension Lid Label.jpg
1200 mg 1200 mg 120 mg per 30 mL Mag Alu Sim Suspension Lid Label.jpg

NDC 60687- 877-45

Magnesium Hydroxide,
Aluminum Hydroxide, and
Simethicone Suspension

Antacid/Anti-Gas

1200 mg/1200 mg/120 mg per 30 mL

Sugar Free

Delivers 30 mL

SHAKE WELL/Protect from freezing

See package Drug Facts insert for full
prescribing information and storage.

For Institutional Use Only.

American Health Packaging
Columbus, OH 43217

F1761C300125

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
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

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-877-45Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone30 mL in 1 CUP, UNIT-DOSESUSPENSION301
60687-877-51Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone10 in 1 TRAYSUSPENSION101
60687-877-76Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone10 in 1 CASESUSPENSION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-877-45ML - Milliliter60687-8774fb89dce-1888-40f8-88a3-5d2f9e71ce6512025-06-13
60687-877-76ML - Milliliter60687-877a4e44cc3-40c3-4ad2-a7e0-69a34c49feba12025-06-13

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
60687-87760687-877-45, 60687-877-51, 60687-877-76

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLPARABEN3QPI1U3FV8IACT
PROPYLPARABENZ8IX2SC1OHIACT
HYPROMELLOSE 2910 (4000 MPA.S)RN3152OP35IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITOL506T60A25RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
PEPPERMINT OILAV092KU4JHIACT
WATER059QF0KO0RIACT
ALUMINUM HYDROXIDE5QB0T2IUN0ACTIB
MAGNESIUM HYDROXIDENBZ3QY004SACTIB
DIMETHICONE, UNSPECIFIED92RU3N3Y1OACTIB

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 SIMETHICONEAmerican Health Packaging2faf291e-1d62-412a-a05e-e992cb7def6a2025-05-30WarningsExact identifier
ndc (package): 60687-877-76
ndc (package): 60687-877-45
ndc (package): 60687-877-51
ndc (product): 60687-877
ndc11 (package): 60687087751
ndc11 (package): 60687087776
ndc11 (package): 60687087745
spl id: 365e1c8d-d52a-bea1-e063-6394a90a4205
spl set id: 2faf291e-1d62-412a-a05e-e992cb7def6a

Reported adverse events (FAERS/openFDA)#

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