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

Mag-Al Plus XS by

Drug Labeling and Warnings

Mag-Al Plus XS by is a Otc medication manufactured, distributed, or labeled by Cardinal Health 107, LLC. 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:

.

Overbagged with 5 x 30 mL cups per bag, NDC: 55154-9422-5

*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

Distributed by:

Cardinal Health

Dublin, OH 43017

L36154990318

Principal Display Panel

Mag-Al Plus XS

5 Cups

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55154-9422(NDC:0121-1762)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (HYDROXIDE ION - UNII:9159UV381P)	MAGNESIUM HYDROXIDE	2400 mg  in 30 mL
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)	ALUMINUM HYDROXIDE	2400 mg  in 30 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	240 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLPARABEN (UNII: 3QPI1U3FV8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

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: 55154-9422-5	5 in 1 BAG	06/07/2011
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	06/07/2011

Labeler - Cardinal Health (603638201)