Label: CALCIUM CARBONATE suspension

  • 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 July 8, 2021

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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 - 5 mL Cup Tray Label

    NDC 81646-112-05

    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

    Pinnacle Pharma LLC
    Charlotte, NC 28217                    

    Case Label

    Case Label

    Cup Label

    Cup Label

  • INGREDIENTS AND APPEARANCE
    CALCIUM CARBONATE 
    calcium carbonate suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81646-112(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:81646-112-0505 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product12/01/2004
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33112/01/2004
    Labeler - PINNACLE PHARMA LLC (081126970)
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