Label: ADVANCED ANTACID REGULAR STRENGTH- aluminum hydroxide, magnesium hydroxide, dimethicone liquid

  • NDC Code(s): 49348-153-39
  • Packager: STRATEGIC SOURCING SERVICES LLC
  • 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 December 25, 2019

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  • Active ingredients (in each 5 mL teaspoonful)

    Aluminum hydroxide 200mg (equivalent to dried gel, USP)
    Magnesium hydroxide 200 mg
    Simethicone 20mg

  • Purposes

    Antacid

    Antigas

  • Uses

    relieves

    • heartburn
    • sour stomach
    • acid indigestion
    • the symptoms 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 taking a

    prescription drug. Antacids may interact with certain prescription drugs.

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

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

  • Directions

    • shake well before use
    • adults and children 12 years and older: take 2 to 4 teaspoonfuls between meals, at bedtime, or as directed by a doctor
    • do not take more than 24 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks
    • children under under 12 years: ask a doctor
  • Other information

    • each 5 mL teaspoonful contains: magnesium 85 mg, sodium 1 mg
    • protect from freezing
    • store at room temperature
    • keep tightly closed
  • Inactive ingredients

    benzyl alcohol, butylparaben, flavor (contains alcohol), hydroxyethylcellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

  • package label

    Sunmark

    compare to active ingredients of the Regular Strength Mylanta®*

    NDC 49348-153-39

    advanced

    antacid

    Regular Strength

    antacid/antigas

    Alumina, Magnesia
    and Simethicone
    Oral Suspension

    Fast acting
    soothing relief of
    heartburn,
    acid indigestion,
    sour stomach,
    pressure & bloating

    ORIGINAL FLAVOR

    Alcohol 0.15%

    12 FL OZ (355 mL)

    sun rs

  • INGREDIENTS AND APPEARANCE
    ADVANCED ANTACID REGULAR STRENGTH 
    aluminum hydroxide, magnesium hydroxide, dimethicone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-153
    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 CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE200 mg  in 5 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-153-39355 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33106/01/2012
    Labeler - STRATEGIC SOURCING SERVICES LLC (116956644)
    Registrant - GCP Laboratories (965480861)
    Establishment
    NameAddressID/FEIBusiness Operations
    GCP Laboratories965480861manufacture(49348-153)
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