Label: CALCIUM CARBONATE 10 GR (648 MG) (ANTACID) (calcium carbonate 10gr- 648 mg tablet
- NDC Code(s): 0536-1206-10
- Packager: RUGBY LABORATORIES
- 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 December 20, 2022
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INGREDIENTS AND APPEARANCE
CALCIUM CARBONATE 10 GR (648 MG) (ANTACID)
calcium carbonate 10gr (648 mg) tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1206 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE 648 mg Inactive Ingredients Ingredient Name Strength ACACIA (UNII: 5C5403N26O) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape ROUND Size 11mm Flavor Imprint Code PH046 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-1206-10 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/28/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 02/28/2019 Labeler - RUGBY LABORATORIES (079246066) Registrant - Pharbest Pharmaceuticals Inc. (557054835) Establishment Name Address ID/FEI Business Operations Pharbest Pharmaceuticals Inc. 557054835 manufacture(0536-1206) , pack(0536-1206) , label(0536-1206)