ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONE suspension

Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone by

Drug Labeling and Warnings

Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone by is a Otc medication manufactured, distributed, or labeled by American Health Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each 30 mL cup)

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

  Antacid

• Magnesium hydroxide 1200 mg:

  Antacid

• Simethicone 120 mg:

  Antigas

Purpose

Antacid/Antigas

Uses

for the relief of:

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

Warnings

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

• kidney disease
• a magnesium-restricted diet

Ask a doctor or pharmacist before use if you are

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

Stop use and ask a doctor if

symptoms last more than 2 weeks.

Keep out of reach of children

Directions

• 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

• 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

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

Questions or comments?

Call 1-800-845-8210

DO NOT USE IF SEAL IS BROKEN.

Distributed by:

American Health Packaging
Columbus, OH 43217

R01/25

Principal Display Panel – Tray Label

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

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

INGREDIENTS AND APPEARANCE

ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONE 
aluminum hydroxide, magnesium hydroxide, and simethicone suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60687-877
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)	ALUMINUM HYDROXIDE	200 mg  in 5 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P)	MAGNESIUM HYDROXIDE	200 mg  in 5 mL
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O) (DIMETHICONE, UNSPECIFIED - UNII:92RU3N3Y1O)	DIMETHICONE, UNSPECIFIED	20 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLPARABEN (UNII: 3QPI1U3FV8)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
PEPPERMINT OIL (UNII: AV092KU4JH)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60687-877-76	10 in 1 CASE	06/01/2025
1	NDC: 60687-877-51	10 in 1 TRAY
1	NDC: 60687-877-45	30 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M001	06/01/2025

Labeler - American Health Packaging (929561009)