Label: ACYDONE- aluminum hydroxide, magnesium hydroxide, simethicone liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated November 1, 2024

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  • Active Ingredient


    Active ingredient (In each 5 ML Teaspoonful) Purpose
    Aluminium Hydroxide 200 mg Antacid
    Magnesium Hydroxide 200 mg Antacid
    Simeticone 25 mg Anti-gas

    Indications and Usage

    COMPOSITION Each 5 ml of Suspension contains:
    Aluminum hydroxide………..…. 200 mg antacid
    Magnesium Hydroxide ............. 200 mg antacid
    Simethicone ………………….…. 25 mg antiflatulence

    ACYDONE@ GEL is indicated in: Gastric hyperacidity of different origins, gastritis, esophagitis, flatulence, peptic ulcer, adjuvant in the treatment of gastroesophageal reflux, duodenitis, gastrointestinal disorders with excess gas.

  • Purpose


    Use For The Following:

    Relief *Acid Indigestion *Heartburn * Sour Stomach * The Symptoms referred to as gas

  • Warning

    Ask a Doctor if you have:

    Ask a Doctor if you have:

    *kidney disease * a magnesium restricted diet * fever *vomiting * fructose intolerance

    Ask a doctor or pharmacist:

    Ask a Doctor or pharmacist before use if you are taking a prescription drug. Antacid may interact with certain prescription drugs.

    Pregnant/Breastfeeding

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

    Children

    keep out of reach of children

  • Directions

    Shake well before use * Adults and children 12 years of age and older: take 10 ml to 20 ml (2 to 4 teaspoonfuls) between meals, at bed time or as directed by a doctor * Do not take more than 24 teaspoonful in 24 hours. Take Orally.

  • Other Information

    Keep tightly closed *Protect from feezing * do not use after the expiration date *store less than 86 ° F * ask a doctor if symptoms persist

  • Inactive Ingredients

    Sodium saccharin, Sorbitol 70%, Methylparaben, Propylparaben, flavor, Anhydrous citric acid, ethyl alcohol, Xanthan gum, Glycerine, purified water

  • PRINCIPAL DISPLAY PANEL

    Label Front

  • PRINCIPAL DISPLAY PANEL

    Box Full

  • Interior leaflet

    Interior leaflet

  • INGREDIENTS AND APPEARANCE
    ACYDONE 
    aluminum hydroxide, magnesium hydroxide, simethicone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84831-005
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE25 mg  in 5000 mg
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE200 mg  in 5000 mg
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE200 mg  in 5000 mg
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLPARABEN (UNII: Z8IX2SC1OH) 1 mg  in 5000 mg
    MINT (UNII: FV98Z8GITP) 0.25 mg  in 5000 mg
    ALCOHOL (UNII: 3K9958V90M) 40 mg  in 5000 mg
    WATER (UNII: 059QF0KO0R) 3558.3 mg  in 5000 mg
    CHERRY (UNII: BUC5I9595W) 2.5 mg  in 5000 mg
    GLYCERIN (UNII: PDC6A3C0OX) 500 mg  in 5000 mg
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.45 mg  in 5000 mg
    METHYLPARABEN (UNII: A2I8C7HI9T) 5 mg  in 5000 mg
    XANTHAN GUM (UNII: TTV12P4NEE) 17.5 mg  in 5000 mg
    SORBITOL (UNII: 506T60A25R) 400 mg  in 5000 mg
    SODIUM SACCHARIN (UNII: SB8ZUX40TY) 50 mg  in 5000 mg
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorCHERRY, MINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84831-005-015000 mg in 1 BOTTLE; Type 0: Not a Combination Product11/11/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/11/2024
    Labeler - Sigma (815366311)
    Establishment
    NameAddressID/FEIBusiness Operations
    INDUSTRIA QUIMICO FARMACEUTICA SIGMA CORP. S.R.L.815366311manufacture(84831-005)
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