CALCIUM CARBONATE SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]

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CALCIUM CARBONATE SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]
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NDC 0121-0766-16, 0121-4766-05
Set ID d89f3184-7081-4e16-a504-9214283891f6
Category HUMAN OTC DRUG LABEL
Packager Pharmaceutical Associates, Inc.
Generic Name
Product Class
Product Number
Application Number PART331
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5 mL teaspoonful)

    Calcium Carbonate 1250 mg
    (Equivalent to 500 mg elemental Calcium)

  • Purpose

    Antacid

  • Uses

    Relieves:

    • heartburn
    • acid indigestion
    • sour stomach
    • upset stomach associated with these symptoms
  • Warnings

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

    When using this product, do not take more than 6 teaspoonfuls (30 mL) in a 24-hour period or use the maximum dosage for more than 2 weeks.

    Keep out of reach of children.

  • Directions

    • Shake well before using.
    • Take 1 to 2 teaspoonfuls (5 to 10 mL) as symptoms occur, or as directed by a doctor.
  • Other information

    • store at 20° - 25°C (68° - 77°F)
    • do not freeze
    • Calcium Carbonate Oral Suspension is a pink-colored, bubble gum flavored suspension supplied in the following oral dosage forms:
    NDC 0121-0766-16:16 fl oz (473 mL) bottle
    NDC 0121-4766-05:5 mL unit dose cup, in a tray of ten cups.

  • Inactive ingredients

    calcium saccharin, citric acid, D&C Red No. 33, FD&C Red No. 40, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sorbitol and xanthan gum.

  • Questions or comments?

    Call 1-800-845-8210.

    You may also report serious side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    MANUFACTURED BY

    Pharmaceutical Associates, Inc. Greenville, SC 29605

    R07/20

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    NDC 0121-0766-16

    Quality ®
    Value

    Calcium Carbonate
    Oral Suspension

    1250 mg/5 mL

    Maximum Strength
    ANTACID

    Daily source of calcium

    SUGAR FREE / ALCOHOL FREE
    SODIUM FREE

    16 fl oz (473 mL)

    Pharmaceutical
    Associates, Inc.
    Greenville, SC 29605

    Principal Display Panel - 473 mL Bottle Label
  • PRINCIPAL DISPLAY PANEL - 5 mL Cup Tray Label

    NDC 0121-4766-05

    Calcium Carbonate Oral
    Suspension
    Maximum Strength

    1250 mg/5 mL
    (equivalent to 500 mg of elemental Calcium)

    SUGAR FREE/ ALCOHOL FREE/ SODIUM FREE

    ANTACID – SHAKE WELL

    USUAL DOSAGE: See attached Drug Facts

    This unit-dose package is not child-resistant.

    Store at 20° - 25°C (68° - 77°F)
    10 x 5 mL Unit-Dose Cups

    Pharmaceutical
    Associates, Inc.
    Greenville, SC 29605

    T4766050218
    R02/18

    PRINCIPAL DISPLAY PANEL - 5 mL Cup Tray Label
  • INGREDIENTS AND APPEARANCE
    CALCIUM CARBONATE 
    calcium carbonate suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-0766
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE1250 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    SACCHARIN CALCIUM (UNII: 5101OP7P2I)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-0766-1612 in 1 CASE12/01/2004
    1473 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33112/01/2004
    CALCIUM CARBONATE 
    calcium carbonate suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-4766
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE1250 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    SACCHARIN CALCIUM (UNII: 5101OP7P2I)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-4766-054 in 1 CASE12/01/2004
    110 in 1 TRAY
    15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33112/01/2004
    Labeler - Pharmaceutical Associates, Inc. (044940096)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaceutical Associates, Inc.097630693manufacture(0121-0766, 0121-4766)
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