Label: CALCIUM CARBONATE CHEWABLE ANTACID- calcium carbonate tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 68071-4588-5 - Packager: NuCare Pharmaceuticals,Inc.
- This is a repackaged label.
- Source NDC Code(s): 57896-763
- 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 October 4, 2019
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Ask a doctor before use if you
• have kidney disease
• are taking prescription drugs; antacids may interact with certain prescription drugsStop use and ask a doctor if • symptoms last more than 2 weeks.
When using this product • do not use the maximum dosage for more than 2 weeks
If pregnant or breast feeding, ask a health professional before use.
- Directions
- Other information
- Inactive ingredients
- Package label
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INGREDIENTS AND APPEARANCE
CALCIUM CARBONATE CHEWABLE ANTACID
calcium carbonate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68071-4588(NDC:57896-763) 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 500 mg Inactive Ingredients Ingredient Name Strength DEXTROSE (UNII: IY9XDZ35W2) MALTODEXTRIN (UNII: 7CVR7L4A2D) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color red, green, orange, yellow Score no score Shape ROUND Size 14mm Flavor CHERRY, LIME, ORANGE, LEMON Imprint Code AZ;024 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68071-4588-5 150 in 1 BOTTLE; Type 0: Not a Combination Product 10/05/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 01/01/2004 Labeler - NuCare Pharmaceuticals,Inc. (010632300) Establishment Name Address ID/FEI Business Operations NuCare Pharmaceuticals,Inc. 010632300 relabel(68071-4588)