Label: TOPCARE ANTACID- aluminum hydroxide, magnesium hydroxide and dimethicone liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/12

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

  • Active ingredients (in each 5 mL = 1 teaspoonful)

    Aluminum hydroxide (equiv. to dried gel, USP) 200 mg

    Magnesium hydroxide 200 mg

    Simethicone 20 mg

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  • Purpose

    Antacid

    Antigas

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  • Uses

    for the relief of

    acid indigestion
    heartburn
    sour stomach
    upset stomach associated with these symptoms
    pressure and bloating commonly referred to as gas
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  • Warnings

    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.

    When using this product

    do not exceed 16 teaspoonsful (80 mL) in a 24-hour period, or use the maximum dosage for more than 2 weeks, unless directed by a doctor

    Keep out of reach of children.

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  • Directions

    shake well before using
    adults and children 12 years and older: take 2 to 4 teaspoonsful (10-20 mL) four times a day or as directed by a physician
    do not take more than 16 teaspoonsful in 24 hours or use the maximum dosage for more than 2 weeks
    children under 12 years: consult a physician
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  • Other information

    each teaspoonful contains: magnesium 85 mg
    does not meet USP requirements for preservative effectiveness
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  • Inactive ingredients

    butylparaben, flavor, hypromellose, microcrystalline cellulose and carboxymethylcellulose sodium, peppermint oil, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol, sorbitol solution

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  • Questions or comments?

    1-888-423-0139

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  • Principal Display Panel

    REGULAR STRENGTH

    Antacid

    Advanced

    ANTACID & ANTIGAS

    Fast relief of:

    Heartburn

    Acid Indigestion

    Pressure

    Bloating (gas)

    MINT FLAVORED LIQUID

    COMPARE TO MAALOX® ADVANCED active ingredients

    Antacid Front Label Image
    Antacid Back Label Image
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  • INGREDIENTS AND APPEARANCE
    TOPCARE ANTACID 
    aluminum hydroxide, magnesium hydroxide, simethicone liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:36800-851
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE) ALUMINUM HYDROXIDE 200 mg  in 5 mL
    MAGNESIUM HYDROXIDE (MAGNESIUM CATION and HYDROXIDE ION) MAGNESIUM HYDROXIDE 200 mg  in 5 mL
    DIMETHICONE (DIMETHICONE) DIMETHICONE 20 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE  
    BUTYLPARABEN  
    CARBOXYMETHYLCELLULOSE SODIUM  
    HYPROMELLOSES  
    CELLULOSE, MICROCRYSTALLINE  
    PROPYLPARABEN  
    WATER  
    SACCHARIN SODIUM  
    SORBITOL  
    PEPPERMINT OIL  
    Product Characteristics
    Color WHITE (opaque) Score     
    Shape Size
    Flavor MINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:36800-851-40 355 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part332 12/03/2002
    Labeler - Topco Associates LLC (006935977)
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