Mylanta Maximum Strength Vanilla Caramel Flavor Suspension
FDA Label NDC 62372-504

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 Maximum Strength Vanilla Caramel Flavor (NDC 62372-504). 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 10 ml dose), purpose, uses, warnings, 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

Active Ingredients (In Each 10 Ml Dose)

Aluminum hydroxide

(equivalent to dried gel, USP) 800 mg

Magnesium hydroxide 800 mg
Simethicone 80 mg

Purpose

Antacid

Antacid
Anti-gas

Uses

relieves:

  • heartburn
  • pressure and bloating commonly referred to as gas
  • acid indigestion
  • sour stomach
  • upset stomach due to these symptoms
  • 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 use
  •  measure with dosing cup provided
  •  adults and children 12 years and over: 10 mL-20 mL (1-2 doses) 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:

    • magnesium 340 mg; sodium 7 mg

    • store between 20-25°C (68-77°F), do not freeze.

Inactive Ingredients

benzyl alcohol, caramel , carboxymethylcellulose sodium ,flavors, glycerin, microcrystalline cellulose, purified water, sodium carbonate, sorbitol, sucralose, xanthan gum

Questions Or Comment?

call 1-844-695-6624 toll free (English and Spanish)

Principal Display Panel

MYLANTA ®

MAXIMUM STRENGTH

LIQUID ANTACID + ANTI-GAS WORKS ON CONTACT!

  •  
    •  
      •  
        •  
          • Tough on Heartburn
          • Gentle on Your Body

            • SMOOTH CREAMY TASTE

            Vanilla Caramel Flavor

            12 FL OZ (355mL)

            Also try Mylanta Maximum Strength Classic Flavor

            and

            Mylanta Tonight, with its soothing taste of Honey-Chamomile, is perfect for heartburn relief after dinner

            and

            Mylanta GasMinis-great-tasting mini- tablets that relieve gas symptoms fast

            The coating, acid-neutralizing power of New Maximum Strength Mylanta® starts to work on contact.

            It helps soothe and relieve heartburn, acid indigestion, and bothersome gas symptoms so you can feel better fast.

            Tough on heartburn and gas, Mylanta works at the source of symptoms. It is gentle on your body with a great-tasting flavor, and can be used as directed every day.

            • Multi-symptom relief
            • Extra coating power
            • Paraben- free

              • Active ingredients: Aluminum hydroxide, Magnesium hydroxide, Simethicone

              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

              ©2017 Infirst Healthcare Inc.

              Mylanta.com

              Mylanta Liquid Antacid And Antigas Vanilla Caramel Flavor 12 Fl Oz (Label1)

              Mylanta Liquid Antacid And Antigas Vanilla Caramel Flavor 12 Fl Oz (Label1)

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