Mylanta Coat & Cool Drug Facts

Mylanta Coat & Cool Drug Facts
SPL v3
SPL
SPL Set ID b6571f7f-e1ea-4034-a46c-4de1d01beec3
Route
ORAL
Published
Effective Date 2020-02-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Carbonate Ion (1200 mg) Magnesium Cation (270 mg) Dimethicone (80 mg)
Inactive Ingredients
Benzyl Alcohol Carboxymethylcellulose Sodium, Unspecified Form Glycerin Microcrystalline Cellulose Pectin Water Sodium Carbonate Sorbitol Sucralose Sucrose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-10-28

Description

Calcium Carbonate 1200 mg Magnesium Hydroxide 270 mg Simethicone 80 mg

Purpose

Antacid Antacid Anti-gas


Medication Information

Purpose

Antacid

Antacid

Anti-gas

Description

Calcium Carbonate 1200 mg Magnesium Hydroxide 270 mg Simethicone 80 mg

Uses
  • relieves:
    • acid indigestion
    • heartburn
    • sour stomach
    • upset stomach due to these symptoms
    • pressure and bloating commonly referred to as gas
    • overindulgence in food and drink
Directions
  • shake well before using
  • Measure with dosing cup provided
  • adults and children12 years and over:take 10-20 mL (1-2 doses) between meals, at bedtime, or as directed by a doctor
  • do not take more than 60 mL in 24 hours period
  • do not use the maximum dosage for more than 2 weeks
  • children under 12 years:ask a doctor
  • mL-milliliter
Active Ingredient

Calcium Carbonate 1200 mg

Magnesium Hydroxide 270 mg

Simethicone 80 mg

Other Information
  • each 10 mL dose contains:calcium 480 mg; magnesium 115 mg; sodium 4 mg
  • store between 20-25°C (68-77°F), do not freeze.
Inactive Ingredients

benzyl alcohol, carboxymethylcellulose sodium, flavor, glycerin, microcrystalline cellulose, purified water, sodium carbonate, sorbitol, sucralose, sucrose, xanthan gum

Questions Or Comments?

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

Principal Display Panel

Mylanta ®

NDC# 62372-796-12

NEW! Coat & Cool™

2X COATING POWER

CHOCOLATE MINT FLAVOR

WORKS ON CONTACT!

Coats & cools to relieve heartburn fast

Smooth chalky taste

12 FL OZ (355 mL)

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

Mylanta® is Registered Trademark of McNeil Consumer Pharmaceuticals Co.

Infirst

HEALTHCARE

Manufactured for:

Infirst Healthcare Inc.

Westport, CT 06880

© 2019 Infirst Healthcare Inc.

Mylanta.com

Ask A Doctor Before Use If
  • kidney disease
  • a magnesium-restricted diet
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)

Ask A Doctor Or Pharmacist Before Use If

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


Structured Label Content

Uses
  • relieves:
    • acid indigestion
    • heartburn
    • sour stomach
    • upset stomach due to these symptoms
    • pressure and bloating commonly referred to as gas
    • overindulgence in food and drink
Purpose

Antacid

Antacid

Anti-gas

Directions
  • shake well before using
  • Measure with dosing cup provided
  • adults and children12 years and over:take 10-20 mL (1-2 doses) between meals, at bedtime, or as directed by a doctor
  • do not take more than 60 mL in 24 hours period
  • do not use the maximum dosage for more than 2 weeks
  • children under 12 years:ask a doctor
  • mL-milliliter
Active Ingredient (Active ingredient)

Calcium Carbonate 1200 mg

Magnesium Hydroxide 270 mg

Simethicone 80 mg

Other Information (Other information)
  • each 10 mL dose contains:calcium 480 mg; magnesium 115 mg; sodium 4 mg
  • store between 20-25°C (68-77°F), do not freeze.
Inactive Ingredients (Inactive ingredients)

benzyl alcohol, carboxymethylcellulose sodium, flavor, glycerin, microcrystalline cellulose, purified water, sodium carbonate, sorbitol, sucralose, sucrose, xanthan gum

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel

Mylanta ®

NDC# 62372-796-12

NEW! Coat & Cool™

2X COATING POWER

CHOCOLATE MINT FLAVOR

WORKS ON CONTACT!

Coats & cools to relieve heartburn fast

Smooth chalky taste

12 FL OZ (355 mL)

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

Mylanta® is Registered Trademark of McNeil Consumer Pharmaceuticals Co.

Infirst

HEALTHCARE

Manufactured for:

Infirst Healthcare Inc.

Westport, CT 06880

© 2019 Infirst Healthcare Inc.

Mylanta.com

Ask A Doctor Before Use If (Ask a doctor before use if)
  • kidney disease
  • a magnesium-restricted diet
Keep Out of Reach of Children. (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)

Ask A Doctor Or Pharmacist Before Use If (ask a doctor or pharmacist before use if)

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


Advanced Ingredient Data


Raw Label Data

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