Active Ingredients
Calcium carbonate 800 mg
Magnesium hydroxide 270 mg
Simethicone 80 mg
Mylanta Classic Liquid
FDA Label NDC 62372-501
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 Classic (NDC 62372-501). 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, purposes, uses, otc - ask doctor, otc - ask doctor/pharmacist, otc - 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
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
Otc - Ask Doctor
Ask a doctor before use if you have
• kidney disease • a magnesium restricted diet
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
presently taking a prescription drug. Antacids may interact with certain prescription drugs.
Otc - 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.
Directions
• shake well before use • measure with dosing cup provided
• adults and children 12 years and over:
10 mL-20 mL (1-2 doses) as needed, between meals, at bedtime or as directed by a doctor
• do not take more than 60 mL (6 doses) in any 24-hour 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 335 mg; magnesium 120 mg; sodium 8 mg
• store between 20-25°C (68-77°F), do not freeze
Inactive Ingredients
benzoic acid, benzyl alcohol, edetate disodium, flavors, glycerin, glyceryl monostearate, methylcellulose, microcrystalline cellulose, peg-8 stearate, polysorbate 65, purified water, sodium benzoate, sorbic acid, sucralose, xanthan gum
Questions Or Comments?
call 1-844-695-6624 toll free (English and Spanish)
Other
TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING.
infirst +
HEALTHCARE®
Manufactured for:
Infirst Healthcare Inc.
Westport, CT 06880
©2023 Infirst Healthcare Inc.
Mylanta.com
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Package Label.Principal Display Panel
Mylanta ®
LIQUID ANTACID+ANTI-GAS
WORKS ON CONTACT!
Fast relief of heartburn, acid indigestion, and painful gas.
CLASSIC FLAVOR
12 FL OZ (355 mL)
* Please review the disclaimer below.
