MAGSIL ANTACID (LEMON MINT) (ALUMINUM HYDROXIDE DRIED GEL, MAGNESIUM HYDROXIDE, AND SIMETHICONE) TABLET, CHEWABLE [FORTUNE PHARMACAL COMPANY LIMITED]

MAGSIL ANTACID (LEMON MINT) (ALUMINUM HYDROXIDE DRIED GEL, MAGNESIUM HYDROXIDE, AND SIMETHICONE) TABLET, CHEWABLE [FORTUNE PHARMACAL COMPANY LIMITED]
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NDC 51467-100-01
Set ID 8a1783d3-421b-481f-8517-db82cb837b24
Category HUMAN OTC DRUG LABEL
Packager FORTUNE PHARMACAL COMPANY LIMITED
Generic Name
Product Class
Product Number
Application Number PART331
  • 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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