Label: SOHMED ACID REDUCER- aluminum hydroxide and magnesium carbonate tablet, chewable

  • 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 August 19, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients
    (in each chewable tablet)    		Purpose
    Aluminum hydroxide 160 mgAntacid
    Magnesium carbonate 105 mgAntacid
  • Use

    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 or sodium-restricted diet

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

    When using this product do not take more than 16 tablets in a 24-hour period or use the maximum dosage for more than 2 weeks

    Keep out of reach of children

  • Directions

    • chew 2 to 4 tablets four times a day or as directed by a doctor.
    • take after meals and at bedtime or as needed
    • for best results follow by a half glass of water or other liquid
    • do not swallow whole
  • Other information

    • each tablet contains :
      magnesium 50 mg and sodium 32 mg
    • store at 20° -25°C.
    • See end flap for expiration date and lot number.
  • Inactive ingredients

    alginic acid, calcium stearate, flavor, mannitol, sodium bicarbonate, starch, sucrose, water, FD&C Yellow # 5 (tartrazine), FD&C Yellow # 6, lactose, dextrose, talcum, sucralose

  • Question or comments ?

    1 (856) 2863646

  • SPL UNCLASSIFIED SECTION

    Distributed by : Sohm, Inc.
    6920 Knott Ave., Suit A-C
    Buena Park, CA 90621

  • PRINCIPAL DISPLAY PANEL - 50 Tablet Bottle Carton

    NDC XXXXXXXXXXX

    SohMed™

    *Compare to the active ingredients in Gaviscon® Extra Strength Antacid

    Extra Strength

    Acid Reducer Antacid

    Aluminum Hydroxide 160 mg
    Magnesium Carbonate 105 mg

    Relieves Heartburn, Acid Indigestion and Sour Stomach

    50 Tablets

    Chewable Tablet

    PRINCIPAL DISPLAY PANEL - 50 Tablet Bottle Carton
  • INGREDIENTS AND APPEARANCE
    SOHMED ACID REDUCER 
    aluminum hydroxide and magnesium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50405-002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE160 mg
    MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE105 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALGINIC ACID (UNII: 8C3Z4148WZ)  
    CALCIUM STEARATE (UNII: 776XM7047L)  
    MANNITOL (UNII: 3OWL53L36A)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    WATER (UNII: 059QF0KO0R)  
    SUCROSE (UNII: C151H8M554)  
    FD&C YELLOW No. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    LACTOSE (UNII: J2B2A4N98G)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    TALC (UNII: 7SEV7J4R1U)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeROUNDSize18mm
    FlavorTROPICAL FRUIT PUNCHImprint Code CRX
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50405-002-501 in 1 CARTON
    150 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33108/25/2013
    Labeler - SOHM Inc. (009303848)
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