Label: RULOX REGULAR- aluminum hydroxide, magnesium hydroxide, dimethicone suspension

  • 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 July 17, 2012

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  • Active ingredients (in each 5 mL teaspoonful)

    Aluminum hydroxide 200 mg (equivalent to dried gel, USP) Magnesium hydroxide 200 mg Simethicone 20mg

  • Purposes

    Antacid Antigas


  • Uses

    relieves

    • heartburn
    • sour stomach
    • acid indigestion
    • the symptoms referred to as gas
  • Warnings

    • kidney disease • a magnesium-restricted diet taking a prescription drug. Antacids may interact with certain prescription drugs. symptoms last more than 2 weeks Ask a doctor before use if you have


    Ask a doctor or pharmacist before use if you are



    Stop use and ask a doctor if

    Keep out of reach of children.

  • Directions

    • shake well before use • adults and children 12 years and older: take 2 to 4 teaspoonfuls four times a day, or as directed by a doctor • do not take more than 16 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks • children under 12 years: ask a doctor



  • Other information

    • magnesium 85 mg, sodium 1 mg • store at room temperature each 5 mL teaspoonful contains:

    • protect from freezing  • keep tightly closed

    • TAMPER-EVIDENT: Do not use if breakaway band on bottle is missing or broken.

  • Inactive ingredients

    benzyl alcohol, butylparaben, carboxymethylcellulose sodium, flavor, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

    Questions or comments?

    Call 1-800-645-2158, 9am -5 pm ET, Monday-Friday

  • RULOX REGULAR (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION

    Label Image
  • INGREDIENTS AND APPEARANCE
    RULOX REGULAR  
    aluminum hydroxide, magnesium hydroxide, dimethicone suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64725-1945(NDC:0536-1945)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE200 mg  in 5 mL
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE200 mg  in 5 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64725-1945-1355 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33101/05/2011
    Labeler - TYA Pharmaceuticals (938389038)
    Registrant - TYA Pharmaceuticals (938389038)
    Establishment
    NameAddressID/FEIBusiness Operations
    TYA Pharmaceuticals938389038RELABEL(64725-1945) , REPACK(64725-1945)
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