Label: ALMACONE liquid

  • 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 February 15, 2011

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  • Active ingredients

    Aluminum Hydroxide 200mg

    Magnesium Hydroxide 200mg

  • PURPOSE

  • Keep Out of Reach of Children

  • Uses

    Use(s)

    Enter section text here

    Uses relieves

    • heartburn

    • acid indigestion

    • sour stomach

    • gas associated with these conditions

  • 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 taking a prescription drug. Antacids may interact with certain prescription drugs.

    Stop use and ask a doctor if syptoms last more than 2 weeks.

    KEEP OUT OF REACH OF CHILDREN.

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

  • Directions

    Shake well before use. Do not take more than 24 teaspoonful in 24 hours or use the maximum dosage for more than 2 weeks. Adults and children 12 years and older: take 2 to 4 teaspoonsfuls between meals, at bedtime, or as directed by a doctor.

    Children under 12 years: ask a doctor.

  • Other Information

    Each 5 mL teaspoon contains:

    magnesium 25 mg, sodium 1 mg. Store at room temperature. Protect from freezing. Keep tighly closed.

  • Inactive ingredients

    Benzoyl alcohol, butylparaben, carboxy methylcellulose sodium, flavor, hypromelloses, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution.

  • How Supplied

    Almacone (antacid) is supplied in 12 oz. bottles NDC 21695-840-12

    Questions or comments?

    Call 1-800-645-2158, 9 am - 5 pm EST, Monday-Friday.

    Distributed by:

    Rugby Laboratories

    Duluth, GA 30097

    Repackaged by:

    Rebel Distributors Corp

    Thousand Oaks, CA 91320

  • Package/Label Principal Display Panel

    Almacone (Antacid) 200mg/ 200mg/ 20mg

  • INGREDIENTS AND APPEARANCE
    ALMACONE 
    almacone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-840(NDC:0536-0025)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE200 mg  in 5 mL
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM HYDROXIDE - UNII:NBZ3QY004S) MAGNESIUM HYDROXIDE200 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21695-840-12355 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33111/11/2008
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distributors Corp118802834RELABEL, REPACK
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