Mag-al Plus Xs

Mag-al Plus Xs
SPL v8
SPL
SPL Set ID db0c47ab-5296-4195-9fa6-2e338b665094
Route
ORAL
Published
Effective Date 2019-07-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aluminum Hydroxide (400 mg) Hydroxide Ion (40 mg) Dimethicone
Inactive Ingredients
Butylparaben Propylparaben Hypromellose 2910 (4000 Mpa.s) Propylene Glycol Sorbitol Saccharin Sodium Peppermint Oil Cyclomethicone 4 Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2004-01-14

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach due to these symptoms
  • pressure and bloating commonly referred to as gas
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50570-1

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.

Section 55105-1
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
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.

Stop Use and Ask A Doctor If
  • symptoms last more than 2 weeks.
Ask A Doctor Before Use If You Have
  • kidney disease
  • a magnesium-restricted diet
Principal Display Panel 30 Ml Cup Tray Label

Delivers 30 mL

NDC 0121-1762-30

MAG-AL PLUS XS



Each 30 mL contains:

Magnesium Hydroxide 2400 mg

Aluminum Hydroxide 2400 mg

Simethicone 240 mg

SHAKE WELL

Package Not Child-Resistant

Pharmaceutical Associates, Inc.

Greenville, SC 29605

See Insert

Ask A Doctor Or Pharmacist Before Use If You Are
  • presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Structured Label Content

Uses
  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach due to these symptoms
  • pressure and bloating commonly referred to as gas
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50570-1 (50570-1)

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.

Section 55105-1 (55105-1)
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
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 (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 (Inactive ingredients)

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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • symptoms last more than 2 weeks.
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • kidney disease
  • a magnesium-restricted diet
Principal Display Panel 30 Ml Cup Tray Label (PRINCIPAL DISPLAY PANEL - 30 mL Cup Tray Label)

Delivers 30 mL

NDC 0121-1762-30

MAG-AL PLUS XS



Each 30 mL contains:

Magnesium Hydroxide 2400 mg

Aluminum Hydroxide 2400 mg

Simethicone 240 mg

SHAKE WELL

Package Not Child-Resistant

Pharmaceutical Associates, Inc.

Greenville, SC 29605

See Insert

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)