Label: CALCIUM CARBONATE 500 MG- calcium carbonate tablet, chewable
-
Contains inactivated NDC Code(s)
NDC Code(s): 68071-2345-5 - Packager: NuCare Pharmaceuticals,Inc.
- This is a repackaged label.
- Source NDC Code(s): 69618-020
- 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 February 8, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each chewable tablet)
- Purpose
- INDICATIONS & USAGE
- Warnings
- ASK DOCTOR/PHARMACIST
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CALCIUM CARBONATE 500 MG
calcium carbonate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68071-2345(NDC:69618-020) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE 500 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) D&C RED NO. 27 (UNII: 2LRS185U6K) DEXTROSE (UNII: IY9XDZ35W2) Product Characteristics Color blue (Light Blue) , orange (Light Orange) , yellow (Light Yellow) , purple (Light Purple) Score no score Shape ROUND Size 16mm Flavor ORANGE (assorted fruit) Imprint Code AP;043 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68071-2345-5 150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/08/2021 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 11/01/2015 Labeler - NuCare Pharmaceuticals,Inc. (010632300) Establishment Name Address ID/FEI Business Operations NuCare Pharmaceuticals,Inc. 010632300 relabel(68071-2345)
