aluminum hydroxide, magnesium hydroxide, simethicone by LLC Federal Solutions / Safecor Health, LLC

aluminum hydroxide, magnesium hydroxide, simethicone by

Drug Labeling and Warnings

aluminum hydroxide, magnesium hydroxide, simethicone by is a Otc medication manufactured, distributed, or labeled by LLC Federal Solutions, Safecor Health, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE- aluminum hydroxide, magnesium hydroxide, dimethicone suspension 
LLC Federal Solutions

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Active ingredients (in each 5 mL teaspoonful)

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

Magnesium hydroxide 400 mg

Simethicone 40 mg

Purpose

Antacid

Antacid

Antigas

Uses

For the relief of

• acid indigestion
• heartburn
• sour stomach
• the symptoms of gas associated with acid indigestion, heartburn, and sour stomach

Warnings

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

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

Keep this and all drugs out of reach of children.

When using this product you may get constipated

Directions

• shake well before use
• do not take more than 8 teaspoonfuls in 24 hours
• do not use the maximum dosage for more than 2 weeks
• dosage: adults and children 12 years and older: 2 to 4 teaspoonfuls two times a day or as directed by a doctor
• children under 12 years: ask a doctor

Other information

• each 5 mL teaspoonful contains: magnesium 165 mg, sodium 1 mg
• store at room temperature
• keep tightly closed

Inactive ingredients

benzyl alcohol, butylparaben, caramel, color, carboxymethylcellulose sodium, D&C yellow #10, flavor, purified water, saccharin sodium, sorbitol solution

Repackaged by:
Safecor Health, LLC
317 New Boston St.
Woburn, MA 01801

Distributed by: LLC Federal Solutions
14 NE 1st Ave.
Miami, FL 33132

———PRINCIPAL DISPLAY PANEL———
NDC: 24451-725-30
DELIVERS 30 mL CONTAINING:
ALUMINUM HYDROXIDE 2400 mg
MAGNESIUM HYDROXIDE 2400 mg
SIMETHICONE 240 mg
(MINTOX)
MAXIMUM STRENGTH
ORAL SUSPENSION
ANTACID / ANTIGAS
SHAKE WELL BEFORE USE
LEMON CREME
Exp: 00/00/00   Lot # 00000

Rpk By: Safecor Health LLC
Woburn, MA 01801
Dist. By: LLC Federal Solutions
Miami, FL 33132

ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE 
aluminum hydroxide, magnesium hydroxide, dimethicone suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24451-725(NDC: 0904-5725)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)	ALUMINUM HYDROXIDE	400 mg  in 5 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM HYDROXIDE	400 mg  in 5 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	40 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CARAMEL (UNII: T9D99G2B1R)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	LEMON (LEMON CREME)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24451-725-30	100 in 1 BOX	08/12/2013	12/31/2019
1		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 final	part331	08/12/2013	12/31/2019

Labeler - LLC Federal Solutions (965036895)

Establishment
Name	Address	ID/FEI	Business Operations
Safecor Health, LLC		828269675	repack(24451-725)

Revised: 1/2020

Document Id: 2b5ec848-6415-48c0-9b20-4c360a36de85

34390-5

Set id: fc3c5c56-772f-44f8-b42f-88909ad68a5e

Version: 2

Effective Time: 20200107