Label: MELOX- aluminum hydroxide, magnesium hydroxide, simethicone 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 November 25, 2020

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredients (in each 5 mL teaspoonful)

    Aluminum hydroxide 200 mg (equivalent to dried gel USP)

    Magnesium hydroxide 200 mg

    Simethicone 20 mg

  • Purpose

    Antacid

    Antacid

    Antigas

  • Uses

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

  • Warnings

    Ask a doctor before use if you have

    • kidney disease  • magnesium-restricted diet

    Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.

    Stop use and ask a doctor if symptoms last more than 2 weeks

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

    Keep out of reach of children.

  • Directions

    • shake well before each use

    • adults and children 12 years and older: take 2 to 4 teaspoonfuls between meals, at bedtime, or as directed by a doctor

    • do not exceed 16 teaspoonfuls in a 24 hour period or use the maximum dosage for more than 2 weeks

    • children under 12: ask a doctor

  • Other information

    each 5 mL teaspoonful contains: magnesium 85 mg, sodium 3 mg

    • store at room temperature

    • protect from freezing

    • keep tightly closed

  • Inactive ingredients

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

  • Questions or comments?

    1-888-779-2877

  • SPL UNCLASSIFIED SECTION

    HEARTBURN RELIEF

    TAMPER EVIDENT: Do not use if breakaway band on cap is broken or missing.

    ​*This product is not manufactured or distributed by the owner of the registered trademark Maalox®

    Distributed by: Belmora LLC,
    2011 Crystal Dr.#400,
    Arlington, VA 22202
    www.melox.com

  • Packaging

    Melox1

  • INGREDIENTS AND APPEARANCE
    MELOX 
    aluminum hydroxide, magnesium hydroxide, simethicone suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27854-115
    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) 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, UNSPECIFIED FORM (UNII: K679OBS311)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:27854-115-01355 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33106/01/2018
    Labeler - Belmora LLC (112753244)