RUGBY ALMACONE (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) SUSPENSION [RUGBY LABORATORIES]

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RUGBY ALMACONE (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) SUSPENSION [RUGBY LABORATORIES]
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NDC 0536-1185-83
Set ID 7f06d5b8-e781-416a-bcec-44d9650cac0c
Category HUMAN OTC DRUG LABEL
Packager Rugby Laboratories
Generic Name
Product Class
Product Number
Application Number PART331
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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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