Label: MAGSIL ANTACID (LEMON MINT)- aluminum hydroxide dried gel, magnesium hydroxide, and simethicone tablet, chewable

  • NDC Code(s): 51467-100-01
  • Packager: FORTUNE PHARMACAL COMPANY LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 22, 2021

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  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)
    Aluminum hydroxide dried gel 200 mg
    Magnesium hydroxide 200 mg
    Simethicone 21 mg

  • PURPOSE

    Purpose
    Antacid
    Antacid
    Antiflatulent

  • INDICATIONS & USAGE

    Uses
    ■ for the relief of pressure and bloating commonly referred to as gas, associated with the following:
       ■ heartburn
       ■ sour stomach
       ■ acid indigestion

  • WARNINGS

    Warnings
    Do not use
    ■ more than 12 tablets in a 24-hour period
    ■ the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor

  • ASK DOCTOR

    Ask a doctor before use if you have
    ■ kidney disease
    ■ a magnesium-restricted diet

  • 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.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of the reach of children.

  • DOSAGE & ADMINISTRATION

    Directions
    ■ adults and children 12 years of age or older: take two tablets, well chewed, 30 minutes after meals, at bedtime, or when symptoms occur, or as directed by a physician. Do not exceed 12 tablets in 24 hours.
    ■ children under 12 years of age: consult a doctor

  • OTHER SAFETY INFORMATION

    Other information
    ■ each chewable tablet contains: 85 mg of magnesium
    ■ Phenylketonurics: Contains Phenylalanine 1.684 mg Per Chewable Tablet
    ■ keep tightly sealed
    ■ store below 25 C (77 F) in a dry place, away from direct sunlight

  • INACTIVE INGREDIENT

    Inactive ingredients
    aspartame, corn starch, D&C yellow no. 10 aluminum lake, lemon flavor, magnesium stearate, mannitol, peppermint flavor, povidone K30

  • QUESTIONS

    Questions or comments? (888) 221-3496 M-F 9 am to 5 pm
    ■ you may also report serious side effects to this phone number

  • PRINCIPAL DISPLAY PANEL

    MAGSIL Antacid

    Lemon Mint

    Safely Sealed

    NDC 51467-100-01

    Aluminum Hydroxide Dried Gel - Antacid
    Magnesium Hydroxide - Antacid
    Simethicone - Antiflatulent

    Recommended for
    ■ Gas
    ■ Sour Stomach
    ■ Heartburn
    ■ Acid Indigestion

    24 Tablets

    In Individually Sealed Strip

    Sugar Free
    IMAGE OF 24 TABLETS BOX

  • INGREDIENTS AND APPEARANCE
    MAGSIL ANTACID (LEMON MINT) 
    aluminum hydroxide dried gel, magnesium hydroxide, and simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51467-100
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE200 mg
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE200 mg
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE21 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize16mm
    FlavorLEMON, MINTImprint Code MAGSIL;FORTUNE
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51467-100-014 in 1 BOX09/22/2017
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33109/20/2017
    Labeler - FORTUNE PHARMACAL COMPANY LIMITED (686280561)
    Establishment
    NameAddressID/FEIBusiness Operations
    FORTUNE PHARMACAL COMPANY LIMITED686280561manufacture(51467-100)
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