Label: CALCIUM CARBONATE suspension
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Contains inactivated NDC Code(s)
NDC Code(s): 81646-112-05 - Packager: PINNACLE PHARMA LLC
- This is a repackaged label.
- Source NDC Code(s): 0121-0766
- 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
- Active ingredient (in each 5 mL teaspoonful)
- Purpose
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredients
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- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 5 mL Cup Tray Label
NDC 81646-112-05
Calcium Carbonate Oral
Suspension
Maximum Strength1250 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 CupsPinnacle Pharma LLC
Charlotte, NC 28217Case Label
Cup Label
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INGREDIENTS AND APPEARANCE
CALCIUM CARBONATE
calcium carbonate suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81646-112(NDC:0121-0766) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE 1250 mg in 5 mL Inactive Ingredients Ingredient Name Strength 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 Color pink Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81646-112-05 05 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 12/01/2004 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 12/01/2004 Labeler - PINNACLE PHARMA LLC (081126970)