Label: RUGBY ALMACONE- 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 January 7, 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

  • Purposes

    Antacid

    Antigas

  • Uses

    relieves

    •
    heartburn
    •
    acid indigestion
    •
    sour stomach
    •
    upset stomach due to 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 exceed 120 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.

    In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • Directions

    •
    shake well before use
    •
    measure with dosing cup provided
    •
    adults and children 12 years and over: 10 mL – 20 mL between meals, at bedtime or as directed by a doctor
    •
    do not take more than 120 mL in any 24 hour period
    •
    do not use the maximum dosage for more than 2 weeks
    •
    children under 12 years: ask a doctor
    •
    mL = milliliter
  • Other information

    •
    each 10 mL contains: magnesium 175 mg
    •
    does not meet USP requirements for preservative effectiveness
    •
    store at 20-25°C (68-77°F), do not freeze
  • Inactive ingredients

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

  • Questions or comments?

    1-800-645-2158

  • Principal Display Panel

    Regular Strength

    Almacone®

    Aluminum Hydroxide

    Magnesium Hydroxide, Simethicone

    ANTACID

    ANTIGAS

    VERY LOW SODIUM

    12 fl oz (355 mL)

    ALCOHOL 0.2%

    almacone image
  • INGREDIENTS AND APPEARANCE
    RUGBY ALMACONE 
    aluminum hydroxide, magnesium hydroxide, simethicone suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1185
    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)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorWHITE (opaque) Score    
    ShapeSize
    FlavorMINT, LEMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1185-83355 mL in 1 BOTTLE; Type 0: Not a Combination Product12/19/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33112/19/2018
    Labeler - Rugby Laboratories (079246066)
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