Label: RIGINIC ANTACID LIQUID- aluminum hydroxide and magnesium carbonate liquid

  • 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 April 30, 2018

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  • Active ingredient (in each 15mL tablespoonful)

    Aluminum Hydroxide 95mg

    Magnesium Carbonate, Anhydrous 358mg

  • Purpose

    Antacid

  • Uses

    relieves

    •
    heartburn
    •
    acid indigestion
    •
    sour stomach
    •
    upset stomach associated with these symptoms
  • Warnings

    Ask a doctor before use if you have

    •
    kidney disease
    •
    a magnesium-restricted diet
    •
    a sodium-restricted diet

    Ask a doctor or pharmacist before use if you are

    •
    taking a prescription drug. Antacids may interact with certain prescription drugs.

    When using this product,

    •
    it may have a laxative effect
  • Stop use and ask a doctor if

    symptoms last more than two weeks

  • Keep out of reach of children.

  • Directions

    •
    shake well before using
    •
    do not take more than 8 tablespoons in 24 hours
    •
    do not use the maximum dosage for more than 2 weeks
    •
    dosage: 1-2 tablespoons after meals and at bedtime followed by milk or water
  • Other information

    •
    TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING
    •
    each tablespoon contains: sodium 19 mg, magnesium 124 mg, calcium 3 mg
    •
    Store at room temperature 15º - 25ºC (59º - 77ºF)
    •
    keep tightly closed
    •
    avoid freezing
  • Inactive ingredients

    colors, edetate disodium, flavors, glycerin, methylparaben, propylparaben, saccharin, sodium alginate, sodium hypochlorite, sorbitol solution, water, xanthan gum

  • Principal Display Panel

    Regular Strength 12 fl oz label

  • INGREDIENTS AND APPEARANCE
    RIGINIC ANTACID LIQUID 
    aluminum hydroxide and magnesium carbonate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53807-137
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE95 mg  in 15 mL
    MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE358 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SACCHARIN (UNII: FST467XS7D)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorMINT (cool mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53807-137-12355 mL in 1 BOTTLE; Type 0: Not a Combination Product04/03/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33104/03/2013
    Labeler - Rij Pharmaceutical Corporation (144679156)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rij Pharmaceutical Corporation144679156manufacture(53807-137)
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