Active Ingredients (In Each Tablet)
Calcium carbonate 1000mg
Magnesium hydroxide 270mg
Simethicone 80mg
Mylanta One Antacid/anti-gas Tablet, Chewable
FDA Label NDC 62372-552
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 One Antacid/anti-gas (NDC 62372-552). 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 ingredients (in each tablet), purposes, uses, warnings, keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Antacid
Antacid
Anti-gas
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
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
▪ adults and children 12 years and over: chew 1 tablet as symptoms occur, or as directed by doctor▪ do not take more than 6 tablets in 24 hours▪ do not use the maximum dosage for more than 2 weeks▪ children under 12 years of age: ask a doctor
Other Information
▪ each chewable tablet contains: calcium 400mg, magnesium 115mg▪ store between 20-25°C (68-77°F)
Inactive Ingredients
adipic acid, crospovidone, dextrose, FD&C Red #40 Lake, flavors, magnesium stearate, maltodextrin, sucralose
Questions?
call 1-844-695-6624 toll free (English and Spanish)
Other
Fast, powerful multi-symptom relief in a great-tasting ONE tablet dose.
TAMPER-EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING
Mylanta® is a Registered Trademark of McNeil Consumer Pharmaceuticals Co.
Infirst Healthcare
Manufactured for:
Infirst Healthcare Inc.
Westport, CT 06880.
©2021 Infirst Healthcare Inc.
Mylanta.com
Package/Label Principal Display Panel
Mylanta One Antacid/anti-gas Chewable Tablets (Berry Ginger)
NEW!
3 POWERFUL INGREDIENTS IN ONE
Mylanta®
ONETM
ANTACID + ANTI-GAS
WORKS IN ONE TABLET
WITH A SMOOTH SOOTHING TASTE!
50 SINGLE DOSE CHEWABLE TABLETS
BERRY
GINGER
* Please review the disclaimer below.
