Your browser does not support JavaScript! APCAL (CALCIUM CARBONATE AND VITAMIN D3) TABLET [A P J LABORATORIES LIMITED]
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APCAL (calcium carbonate and vitamin d3) tablet
[A P J Laboratories limited]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Sections

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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product
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 Calcium Carbonate 1250 mg Vitamin D3 250 IU
APCAL 
calcium carbonate and vitamin d3 tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46084-071
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (CALCIUM CATION and CARBONATE ION) CALCIUM CARBONATE1250 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL250 [iU]
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN20 mg
GELATIN2 mg
METHYLPARABEN2 mg
TITANIUM DIOXIDE.1 mg
MAGNESIUM STEARATE20 mg
TALC20 mg
SODIUM STARCH GLYCOLATE TYPE A POTATO10 mg
SILICON DIOXIDE10 
Product Characteristics
Colorwhite (White) Scorescore with uneven pieces
ShapeCAPSULE (scoreline) Size20mm
FlavorImprint Code 1335mg
Contains    
Packaging
#Item CodePackage Description
1NDC:46084-071-16500 in 1 BLISTER PACK
2NDC:46084-071-15250 in 1 BLISTER PACK
3NDC:46084-071-14120 in 1 BLISTER PACK
4NDC:46084-071-1360 in 1 BLISTER PACK
5NDC:46084-071-1230 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33103/01/2013
Labeler - A P J Laboratories limited (677378339)
Registrant - A P J Laboratories limited (677378339)
Establishment
NameAddressID/FEIBusiness Operations
A P J Laboratories limited677378339manufacture(46084-071)

Revised: 02/2013
Document Id: 8747131c-4c0b-4306-8bd9-b29cefb71296
Set id: 51edd66f-8855-469b-8252-ed0d9e6cdaec
Version: 2
Effective Time: 20130221
 
A P J Laboratories limited

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