FDA Label for Mylanta Coat And Cool
View Indications, Usage & Precautions
Mylanta Coat And Cool Product Label
The following document was submitted to the FDA by the labeler of this product Infirst Healthcare Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
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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