Label: CAREONE 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 5, 2019

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  • Active ingredients (in each 10 mL)

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

    Magnesium hydroxide 400 mg

    Simethicone 40 mg

  • Purpose

    Antacid

    Antigas

  • Uses

    for the relief of

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

  • 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
  • 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
  • Inactive ingredients

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

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    ADVANCED REGULAR STRENGTH LIQUID ANTACID

    Aluminum Hydroxide, Magnesium Hydroxide, Simethicone

    Antacid/Antigas

    Cooling Mint Flavor

    Soothing Relief of Heartburn, Acid Indigestion, Bloating (Gas), Pressure

    Gluten Free

    12 FL OZ (355 mL)

    OUR PHARMACISTS RECOMMEND

    851-of-liquid-antacid.jpg
  • INGREDIENTS AND APPEARANCE
    CAREONE ANTACID 
    aluminum hydroxide, magnesium hydroxide, simethicone suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-851
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE400 mg  in 10 mL
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE400 mg  in 10 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE40 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorWHITE (opaque) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-851-40355 mL in 1 BOTTLE; Type 0: Not a Combination Product10/12/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33210/12/2012
    Labeler - American Sales Company (809183973)
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