MAG-AL PLUS- aluminum hydroxide, magnesium hydroxide, and simethicone suspension

Mag-AL Plus by

Drug Labeling and Warnings

Mag-AL Plus by is a Otc medication manufactured, distributed, or labeled by Pharmaceutical Associates, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 5 mL = 1 teaspoonful)	Purpose
Aluminum hydroxide (equiv. to dried gel, USP) 200 mg	Antacid
Magnesium hydroxide 200 mg	Antacid
Simethicone 20 mg	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 16 teaspoonfuls 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 16 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 four times a day or as directed by a physician
• children under 12 years: consult a physician

Other information

• each 5 mL contains: magnesium 83 mg, sodium 1.34 mg
• store at controlled room temperature 20° - 25°C (68° - 77°F)
• protect from freezing
• White colored, peppermint flavored liquid supplied in the following oral dosage form:

• NDC: 0121-1761-30: 30 mL unit dose cup. Case contains 100 unit dose cups of 30 mL packaged in 10 trays of 10 unit dose cups each.

Inactive ingredients

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

Questions or comments?

Call 1-800-845-8210

SPL UNCLASSIFIED SECTION

MANUFACTURED BY

Pharmaceutical
Associates, Inc.
Greenville, SC 29605

PRINCIPAL DISPLAY PANEL - 30 mL Unit-Dose Cup Tray Label

*Compare to the
active ingredients
in Maalox ®

NDC: 0121-1761-30

MAG-AL PLUS
Antacid/ Anti-Gas
Sugar Free

Each 30 mL contains:

Aluminum Hydroxide
1200 mg

Magnesium Hydroxide
1200 mg

Simethicone
120 mg

SHAKE WELL

USUAL DOSAGE: See attached Drug Facts

This unit-dose package is not child-resistant.

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

10 x 30 mL Unit-Dose Cups

Pharmaceutical
Associates, Inc.
Greenville, SC 29605

T1761300519
R05/19

INGREDIENTS AND APPEARANCE

MAG-AL PLUS 
aluminum hydroxide, magnesium hydroxide, and simethicone suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0121-1761
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 (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	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)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
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: 0121-1761-30	10 in 1 CASE	01/14/2004
1		10 in 1 TRAY
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	01/14/2004

Labeler - Pharmaceutical Associates, Inc. (044940096)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmaceutical Associates, Inc.		097630693	manufacture(0121-1761)