MAG-AL PLUS XS- aluminum hydroxide, magnesium hydroxide, and dimethicone 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) 400 mg	Antacid
Magnesium hydroxide 400 mg	Antacid
Simethicone 40 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 8 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 8 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 two times a day or as directed by a physician
• children under 12 years: consult a physician

Other information

• each 5 mL contains: magnesium 167 mg, sodium 2.24 mg
• store at controlled room temperature 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].
• protect from freezing
• White colored, cherry flavored liquid supplied in the following oral dosage form:

NDC: 0121-1762-30: 30 mL unit dose cup. Case contains 100 unit dose cups of 30 mL packaged in 10 trays of 10 unit dose cups each.

*Maalox is a registered trademark of Novartis Consumer Health, Inc.

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
www.paipharma.com

PRINCIPAL DISPLAY PANEL - 30 mL Cup Tray Label

* Compare to the
active ingredients
in Maalox ® Max™

NDC: 0121-1762-30

MAG-AL PLUS XS
Maximum Strength Antacid/ Anti-Gas
Sugar Free

Each 30 mL contains:

Magnesium Hydroxide 2400 mg
Aluminum Hydroxide 2400 mg
Simethicone 240 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

T1762300519
R05/19

INGREDIENTS AND APPEARANCE

MAG-AL PLUS  XS
aluminum hydroxide, magnesium hydroxide, and dimethicone suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0121-1762
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, HYDROXIDE ION - UNII:9159UV381P)	MAGNESIUM HYDROXIDE	400 mg  in 5 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	40 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: 0121-1762-30	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(0121-1762)