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FDA Approval

Mag-Al Plus

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
May 1, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Aluminum hydroxide(200 mg in 5 mL)
Magnesium hydroxide(200 mg in 5 mL)
Dimethicone 410(20 mg in 5 mL)

Products1

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

Mag-Al Plus

Product Details

NDC Product Code
55154-9429
Application Number
M001
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
ORAL
Effective Date
May 1, 2025
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Code: 5QB0T2IUN0Class: ACTIBQuantity: 200 mg in 5 mL
Code: NBZ3QY004SClass: ACTIBQuantity: 200 mg in 5 mL
BUTYLPARABENInactive
Code: 3QPI1U3FV8Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
Code: 92RU3N3Y1OClass: ACTIBQuantity: 20 mg in 5 mL

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Uses

for the relief of:

acid indigestion

heartburn

sour stomach

upset stomach due to these symptoms

pressure and bloating commonly referred to as gas

DOSAGE & ADMINISTRATION SECTION

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

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

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.


OTC - ACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Questions or comments?

Call 1-800-845-8210


SPL UNCLASSIFIED SECTION

MANUFACTURED BY

Pharmaceutical
Associates, Inc.
Greenville, SC 29605

Distributed By:

Cardinal Health

Dublin, OH 43017

L37247540425

INACTIVE INGREDIENT SECTION

Inactive ingredients

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


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