Label: TOPCARE ANTACID- 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 August 16, 2017

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

  • Active ingredients (in each 10 mL)

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

    Magnesium hydroxide 400 mg

    Simethicone 40 mg

    Close
  • Purpose

    Antacid

    Antigas

    Close
  • Uses

    for the relief of

    acid indigestion
    heartburn
    sour stomach
    upset stomach associated with these symptoms
    pressure and bloating commonly referred to as gas
    Close
  • 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 take more than 80 mL in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician

    Keep out of reach of children.

    Close
  • Directions

    shake well before using
    only use the dose cup provided
    adults and children 12 years and older: take 10 mL to 20 mL four times a day or as directed by a physician
    do not take more than 80 mL in 24 hours or use the maximum dosage for more than 2 weeks
    children under 12 years: consult a physician
    Close
  • Other information

    each 10 mL contains: magnesium 175 mg
    does not meet USP requirements for preservative effectiveness
    store at 20-25ºC (68-77ºF)
    protect from freezing
    Close
  • Inactive ingredients

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

    Close
  • Questions or comments?

    1-888-423-0139

    Close
  • Principal Display Panel

    REGULAR STRENGTH

    Antacid Advanced

    ANTACID & ANTIGAS

    Fast relief of:

    Heartburn

    Acid indigestion

    Pressure

    Bloating (gas)

    MINT FLAVORED

    QUALITY GUARANTEED

    COMPARE TO MAALOX® ADVNACED active ingredients

    12 FL OZ (355 mL)

    851-88-antacid-1.jpg
    851-88-antacid-2.jpg
    Close
  • INGREDIENTS AND APPEARANCE
    TOPCARE ANTACID 
    aluminum hydroxide, magnesium hydroxide, simethicone suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-851
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE 400 mg  in 10 mL
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE 400 mg  in 10 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 40 mg  in 10 mL
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    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; Type 0: Not a Combination Product 12/03/2002
    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)
    Close