Label: ANTACID- aluminum hydroxide, magnesium hydroxide and 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 January 21, 2016

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  • Active ingredient (in each 5mL tsp.)

    Aluminum hydroxide (equvi. to dried gel, USP) 400 mg

    Magnesium hydroxide 400 mg

    Simethicone 40 mg

  • Purpose

    Antacid

    Antacid

    Antigas

  • Uses

    • relieves:
    • acid indigestion
    • heartburn
    • sour stomach
    • upset stomach and gas associated with these symptoms
  • Warnings

    Do not take more than 8 teaspoonfuls in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

    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.

    Stop use and ask a doctor

    if symptoms last more than two weeks

    Keep out of reach of children.
  • Directions

    • shake well before use.
    • adults and children 12 years and older: take 2 to 4 teaspoonfuls two times a day, or as directed by a doctor
    • children under 12 years: consult a doctor
  • Other information

    • each teaspoon contains: magnesium 170 mg, sodium 5 mg
    • store at controlled room temperature 20oC-25oC (68oF-77oF)
    • do not freeze
  • Inactive ingredients

    flavor, glycerin, hydroxyethylcellulose, methylparaben, propylene glycol, purified water, saccharin sodium, simethicone emulsion, sorbitol

  • PDP

    Compare to Maalox maximum strength liquid cherry active ingredients

    Maximum strength

    Antacid Liquid

    Aluminum Hydroxide 400 mg - Antacid

    Magnesium Hydroxide 400 mg - Antacid

    Simethicone 40 mg - Antigas

    LBL

  • INGREDIENTS AND APPEARANCE
    ANTACID 
    aluminum hydroxide, magnesium hydroxide and simethicone suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-508
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE400 mg  in 5 mL
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE400 mg  in 5 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE40 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-508-05177 mL in 1 BOTTLE; Type 0: Not a Combination Product12/12/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33212/12/2015
    Labeler - Safeway (009137209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276manufacture(21130-508)
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