Mylanta Classic

Mylanta Classic
SPL v1
SPL
SPL Set ID 10a4cf29-39ed-87c3-e063-6394a90a4973
Route
ORAL
Published
Effective Date 2024-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calcium Cation (800 mg) Dimethicone (80 mg) Magnesium Cation (270 mg)
Inactive Ingredients
Benzoic Acid Benzyl Alcohol Glycerin Glyceryl Monostearate Microcrystalline Cellulose Methylcellulose, Unspecified Peg-8 Stearate Sodium Benzoate Sorbic Acid Sucralose Polysorbate 65 Edetate Disodium Water Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-31

Description

Calcium carbonate 800 mg Magnesium hydroxide 270 mg Simethicone 80 mg

Purpose

Antacid Antacid Anti-gas


Medication Information

Purpose

Antacid Antacid Anti-gas

Description

Calcium carbonate 800 mg Magnesium hydroxide 270 mg Simethicone 80 mg

Uses

relieves:

• heartburn • acid indigestion • sour stomach

• upset stomach due to these symptoms

• pressure and bloating commonly referred to as gas

• overindulgence in food and drink

Section 42229-5

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

infirst +

HEALTHCARE®

Manufactured for:

Infirst Healthcare Inc.

Westport, CT 06880

©2023 Infirst Healthcare Inc.

Mylanta.com

Lot:

Exp:

Section 50565-1

Keep out of reach of children.

In case of overdose, get medical help or contact a poison control center right away at 1-800-222-1222.

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 51945-4

Mylanta ®

LIQUID ANTACID+ANTI-GAS

WORKS ON CONTACT!

Fast relief of heartburn, acid indigestion, and painful gas.

CLASSIC FLAVOR

12 FL OZ (355 mL)

Purposes

Antacid

Antacid

Anti-gas

Directions

• shake well before use • measure with dosing cup provided

adults and children 12 years and over:

10 mL-20 mL (1-2 doses) as needed, between meals, at bedtime or as directed by a doctor

• do not take more than 60 mL (6 doses) in any 24-hour period

• do not use the maximum dosage for more than 2 weeks

children under 12 years: ask a doctor

• mL=milliliter

Other Information

each 10 mL dose contains:

calcium 335 mg; magnesium 120 mg; sodium 8 mg

• store between 20-25°C (68-77°F), do not freeze

Active Ingredients

Calcium carbonate 800 mg

Magnesium hydroxide 270 mg

Simethicone 80 mg

Inactive Ingredients

benzoic acid, benzyl alcohol, edetate disodium, flavors, glycerin, glyceryl monostearate, methylcellulose, microcrystalline cellulose, peg-8 stearate, polysorbate 65, purified water, sodium benzoate, sorbic acid, sucralose, xanthan gum

Questions Or Comments?

call 1-844-695-6624 toll free (English and Spanish)


Structured Label Content

Uses

relieves:

• heartburn • acid indigestion • sour stomach

• upset stomach due to these symptoms

• pressure and bloating commonly referred to as gas

• overindulgence in food and drink

Section 42229-5 (42229-5)

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

infirst +

HEALTHCARE®

Manufactured for:

Infirst Healthcare Inc.

Westport, CT 06880

©2023 Infirst Healthcare Inc.

Mylanta.com

Lot:

Exp:

Section 50565-1 (50565-1)

Keep out of reach of children.

In case of overdose, get medical help or contact a poison control center right away at 1-800-222-1222.

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 51945-4 (51945-4)

Mylanta ®

LIQUID ANTACID+ANTI-GAS

WORKS ON CONTACT!

Fast relief of heartburn, acid indigestion, and painful gas.

CLASSIC FLAVOR

12 FL OZ (355 mL)

Purposes

Antacid

Antacid

Anti-gas

Directions

• shake well before use • measure with dosing cup provided

adults and children 12 years and over:

10 mL-20 mL (1-2 doses) as needed, between meals, at bedtime or as directed by a doctor

• do not take more than 60 mL (6 doses) in any 24-hour period

• do not use the maximum dosage for more than 2 weeks

children under 12 years: ask a doctor

• mL=milliliter

Other Information (Other information)

each 10 mL dose contains:

calcium 335 mg; magnesium 120 mg; sodium 8 mg

• store between 20-25°C (68-77°F), do not freeze

Active Ingredients (Active ingredients)

Calcium carbonate 800 mg

Magnesium hydroxide 270 mg

Simethicone 80 mg

Inactive Ingredients (Inactive ingredients)

benzoic acid, benzyl alcohol, edetate disodium, flavors, glycerin, glyceryl monostearate, methylcellulose, microcrystalline cellulose, peg-8 stearate, polysorbate 65, purified water, sodium benzoate, sorbic acid, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

call 1-844-695-6624 toll free (English and Spanish)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)