Label: APCAL- calcium carbonate and vitamin d3 tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 46084-071-12, 46084-071-13, 46084-071-14, 46084-071-15, view more46084-071-16 - Packager: A P J Laboratories limited
- Category: HUMAN OTC DRUG LABEL
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 21, 2013
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- Official Label (Printer Friendly)
- WARNINGS
- INACTIVE INGREDIENT
- INACTIVE INGREDIENT
- INACTIVE INGREDIENT
- INACTIVE INGREDIENT
- INACTIVE INGREDIENT
- INACTIVE INGREDIENT
- INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
- ACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
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INGREDIENTS AND APPEARANCE
APCAL
calcium carbonate and vitamin d3 tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46084-071 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 CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 250 [iU] Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) 20 mg GELATIN (UNII: 2G86QN327L) 2 mg METHYLPARABEN (UNII: A2I8C7HI9T) 2 mg TITANIUM DIOXIDE (UNII: 15FIX9V2JP) .1 mg MAGNESIUM STEARATE (UNII: 70097M6I30) 20 mg TALC (UNII: 7SEV7J4R1U) 20 mg SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) 10 mg SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 10 Product Characteristics Color white (White) Score score with uneven pieces Shape CAPSULE (scoreline) Size 20mm Flavor Imprint Code 1335mg Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46084-071-16 500 in 1 BLISTER PACK 2 NDC:46084-071-15 250 in 1 BLISTER PACK 3 NDC:46084-071-14 120 in 1 BLISTER PACK 4 NDC:46084-071-13 60 in 1 BLISTER PACK 5 NDC:46084-071-12 30 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 03/01/2013 Labeler - A P J Laboratories limited (677378339) Registrant - A P J Laboratories limited (677378339) Establishment Name Address ID/FEI Business Operations A P J Laboratories limited 677378339 manufacture(46084-071)
