APCAL - calcium carbonate and cholecalciferol tablet 
A P J Laboratories limited

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.

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Ask a doctor or pharmacist before use if you are taking a prescription drug.

STARCH, CORN

GELATIN

METHYLPARABEN

TITANIUM DIOXIDE

TALC

SODIUM STARCH GLYCOLATE TYPE A POTATO

SILICON DIOXIDE

Keep out of reach of children.

Supplement

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 Calcium Carbonate 1250 mg Vitamin D3 250 IU
APCAL 
calcium carbonate and vitamin d3 tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:46084-071
Route of Administration ORAL DEA Schedule     
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)

Revised: 2/2013
Document Id: 8747131c-4c0b-4306-8bd9-b29cefb71296
Set id: 51edd66f-8855-469b-8252-ed0d9e6cdaec
Version: 2
Effective Time: 20130221
 
A P J Laboratories limited