Drug Facts

Drug Facts
SPL v11
SPL
SPL Set ID 8a1783d3-421b-481f-8517-db82cb837b24
Route
ORAL
Published
Effective Date 2024-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aluminum Hydroxide (200 mg) Magnesium Cation (21 mg) Dimethicone
Inactive Ingredients
Aspartame Starch, Corn D&c Yellow No. 10 Magnesium Stearate Mannitol Povidone K30

Identifiers & Packaging

Pill Appearance
Imprint: MAGSIL;FORTUNE Shape: round Color: yellow Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-09-20

Description

Active ingredients (in each tablet) Aluminum hydroxide dried gel 200 mg Magnesium hydroxide 200 mg Simethicone 21 mg


Medication Information

Warnings and Precautions

Warnings

Do not use

■ more than 12 tablets in a 24-hour period

■ the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor

Indications and Usage

Uses

■ for the relief of pressure and bloating commonly referred to as gas, associated with the following:

   ■ heartburn

   ■ sour stomach

   ■ acid indigestion

Dosage and Administration

Directions

■ adults and children 12 years of age or older: take two tablets, well chewed, 30 minutes after meals, at bedtime, or when symptoms occur, or as directed by a physician. Do not exceed 12 tablets in 24 hours.

■ children under 12 years of age: consult a doctor

Description

Active ingredients (in each tablet) Aluminum hydroxide dried gel 200 mg Magnesium hydroxide 200 mg Simethicone 21 mg

Section 50565-1

Keep this and all drugs out of the reach of children.

Section 50568-5

Ask a doctor or pharmacist before use if you are

■ presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Section 50569-3

Ask a doctor before use if you have

■ kidney disease

■ a magnesium-restricted diet

Section 51727-6

Inactive ingredients

aspartame, corn starch, D&C yellow no. 10 aluminum lake, lemon flavor, magnesium stearate, mannitol, peppermint flavor, povidone K30

Section 51945-4

MAGSIL Antacid

Lemon Mint

Safely Sealed

NDC 51467-100-01

Aluminum Hydroxide Dried Gel - Antacid

Magnesium Hydroxide - Antacid

Simethicone - Antiflatulent

Recommended for

■ Gas

■ Sour Stomach

■ Heartburn

■ Acid Indigestion

24 Tablets

In Individually Sealed Strip

Sugar Free

Section 53413-1

Questions or comments?(888) 221-3496 M-F 9 am to 5 pm

■ you may also report serious side effects to this phone number

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Section 55105-1

Purpose

Antacid

Antacid

Antiflatulent

Section 55106-9

Active ingredients (in each tablet)

Aluminum hydroxide dried gel 200 mg

Magnesium hydroxide 200 mg

Simethicone 21 mg

Section 60561-8

Other information

■ each chewable tablet contains: 85 mg of magnesium

■ Phenylketonurics: Contains Phenylalanine 1.684 mg Per Chewable Tablet

■ keep tightly sealed

■ store below 25 C (77 F) in a dry place, away from direct sunlight


Structured Label Content

Indications and Usage (34067-9)

Uses

■ for the relief of pressure and bloating commonly referred to as gas, associated with the following:

   ■ heartburn

   ■ sour stomach

   ■ acid indigestion

Dosage and Administration (34068-7)

Directions

■ adults and children 12 years of age or older: take two tablets, well chewed, 30 minutes after meals, at bedtime, or when symptoms occur, or as directed by a physician. Do not exceed 12 tablets in 24 hours.

■ children under 12 years of age: consult a doctor

Warnings and Precautions (34071-1)

Warnings

Do not use

■ more than 12 tablets in a 24-hour period

■ the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor

Section 50565-1 (50565-1)

Keep this and all drugs out of the reach of children.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

■ presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Section 50569-3 (50569-3)

Ask a doctor before use if you have

■ kidney disease

■ a magnesium-restricted diet

Section 51727-6 (51727-6)

Inactive ingredients

aspartame, corn starch, D&C yellow no. 10 aluminum lake, lemon flavor, magnesium stearate, mannitol, peppermint flavor, povidone K30

Section 51945-4 (51945-4)

MAGSIL Antacid

Lemon Mint

Safely Sealed

NDC 51467-100-01

Aluminum Hydroxide Dried Gel - Antacid

Magnesium Hydroxide - Antacid

Simethicone - Antiflatulent

Recommended for

■ Gas

■ Sour Stomach

■ Heartburn

■ Acid Indigestion

24 Tablets

In Individually Sealed Strip

Sugar Free

Section 53413-1 (53413-1)

Questions or comments?(888) 221-3496 M-F 9 am to 5 pm

■ you may also report serious side effects to this phone number

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Antacid

Antacid

Antiflatulent

Section 55106-9 (55106-9)

Active ingredients (in each tablet)

Aluminum hydroxide dried gel 200 mg

Magnesium hydroxide 200 mg

Simethicone 21 mg

Section 60561-8 (60561-8)

Other information

■ each chewable tablet contains: 85 mg of magnesium

■ Phenylketonurics: Contains Phenylalanine 1.684 mg Per Chewable Tablet

■ keep tightly sealed

■ store below 25 C (77 F) in a dry place, away from direct sunlight


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)