Active Ingredient (In 10 Ml Dose)
Calcium Carbonate 1200 mg
Magnesium Hydroxide 270 mg
Simethicone 80 mg
Mylanta Coat And Cool Liquid
FDA Label NDC 62372-796
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Infirst Healthcare Inc. for the product Mylanta Coat And Cool (NDC 62372-796). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in 10 ml dose), purpose, uses, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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
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