MYLANTA COAT AND COOL- calcium carbonate, magnesium hydroxide, simethicone liquid

Antacid and Antigas by

Drug Labeling and Warnings

Antacid and Antigas by is a Otc medication manufactured, distributed, or labeled by INFIRST HEALTHCARE INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in 10 mL dose)

Calcium Carbonate 1200 mg

Magnesium Hydroxide 270 mg

Simethicone 80 mg

Purpose

Antacid

Antacid

Anti-gas

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

Warnings

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.

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)

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

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

INGREDIENTS AND APPEARANCE

MYLANTA COAT AND COOL 
calcium carbonate, magnesium hydroxide, simethicone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62372-796
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D)	CALCIUM CARBONATE	1200 mg  in 10 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM HYDROXIDE	270 mg  in 10 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	80 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
PECTIN (UNII: 89NA02M4RX)
WATER (UNII: 059QF0KO0R)
SODIUM CARBONATE (UNII: 45P3261C7T)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHOCOLATE (MINT)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62372-796-12	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/28/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	10/28/2019

Labeler - INFIRST HEALTHCARE INC. (079159739)