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Mag-Al Plus

Mag-AL Plus

Approved
Approval ID

08df7403-9ee3-4a43-a151-c1a6ef7a7549

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 1, 2025

Manufacturers
FDA

Cardinal Health 107, LLC

DUNS: 118546603

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

aluminum hydroxide, magnesium hydroxide, and simethicone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55154-9429
Application NumberM001
Product Classification
M
Marketing Category
C200263
G
Generic Name
aluminum hydroxide, magnesium hydroxide, and simethicone
Product Specifications
Route of AdministrationORAL
Effective DateMay 1, 2025
FDA Product Classification

INGREDIENTS (10)

PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALUMINUM HYDROXIDEActive
Quantity: 200 mg in 5 mL
Code: 5QB0T2IUN0
Classification: ACTIB
MAGNESIUM HYDROXIDEActive
Quantity: 200 mg in 5 mL
Code: NBZ3QY004S
Classification: ACTIB
BUTYLPARABENInactive
Code: 3QPI1U3FV8
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
DIMETHICONE, UNSPECIFIEDActive
Quantity: 20 mg in 5 mL
Code: 92RU3N3Y1O
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/1/2025

Principal Display Panel

NDC 55154-9429-5

MAG-AL PLUS

5 UNIT DOSE CUPS

200mg/200mg/20mg in 5mL; 5x30mL bag label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/1/2025

Uses

for the relief of:

acid indigestion

heartburn

sour stomach

upset stomach due to these symptoms

pressure and bloating commonly referred to as gas

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/1/2025

MANUFACTURED BY

Pharmaceutical
Associates, Inc.
Greenville, SC 29605

Distributed By:

Cardinal Health

Dublin, OH 43017

L37247540425

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/1/2025

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/1/2025

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

WARNINGS SECTION

LOINC: 34071-1Updated: 5/1/2025

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.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 5/1/2025

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:

Overbagged with 5 x 30 mL unit dose cups in each bag, NDC 55154-9429-5

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/1/2025

Inactive ingredients

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/1/2025

Questions or comments?

Call 1-800-845-8210

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Mag-Al Plus - FDA Drug Approval Details