SUPREME ANTACID (CALCIUM CARBONATE, MAGNESIUM HYDROXIDE) SUSPENSION [CHAIN DRUG CONSORTIUM, LLC]

SUPREME ANTACID (CALCIUM CARBONATE, MAGNESIUM HYDROXIDE) SUSPENSION [CHAIN DRUG CONSORTIUM, LLC]
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NDC 68016-624-12
Set ID 60debb08-ce4e-0da0-e053-2a91aa0ae178
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Consortium, LLC
Generic Name
Product Class
Product Number
Application Number PART331
  • Active ingredients (in each 5 mL teaspoonful)

    Calcium carbonate 400 mg
    Magnesium hydroxide 135 mg

  • Purpose

    Antacid

  • Uses

    relieves

    • heartburn
    • sour stomach
    • acid indigestion
    • upset stomach associated with these symptoms
  • 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 each use
    • adults and children 12 years and older: take 2 to 4

    teaspoonfuls, as needed, between meals, at bedtime, or as
    directed by a doctor. Do not take more than 18 teaspoonfuls
    in 24 hours unless directed by a doctor

    • children under 12 years: ask a doctor
  • Other information

    • each 5 mL teaspoonful contains: calcium 160mg, magnesium 55 mg
    • refrigerate after opening to preserve freshness and purity
    • protect from freezing
    • keep tightly closed
    • TAMPER-EVIDENT: Do not use if
      breakaway band on bottle cap is missing or broken.
  • Inactive ingredients

    benzyl alcohol, flavor, hydroxyethylcellulose, purified water, saccharin sodium, simethicone emulsion, sorbic acid, sorbitol solution, xanthan gum

  • package Label

    SUP

  • INGREDIENTS AND APPEARANCE
    SUPREME ANTACID 
    calcium carbonate, magnesium hydroxide suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-624
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE400 mg  in 5 mL
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE135 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SORBIC ACID (UNII: X045WJ989B)  
    SORBITOL (UNII: 506T60A25R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (cherry) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-624-12355 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33105/01/2012
    Labeler - Chain Drug Consortium, LLC (101668460)
    Registrant - GCP Laboratories (965480861)
    Establishment
    NameAddressID/FEIBusiness Operations
    GCP LABORATORIES965480861manufacture(68016-624) , pack(68016-624)

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