APCAL- calcium carbonate and vitamin d3 tablet

APCAL by

Drug Labeling and Warnings

APCAL by is a Otc medication manufactured, distributed, or labeled by A P J Laboratories limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS

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

INACTIVE INGREDIENT

STARCH, CORN

INACTIVE INGREDIENT

GELATIN

INACTIVE INGREDIENT

METHYLPARABEN

INACTIVE INGREDIENT

TITANIUM DIOXIDE

INACTIVE INGREDIENT

TALC

INACTIVE INGREDIENT

SODIUM STARCH GLYCOLATE TYPE A POTATO

INACTIVE INGREDIENT

SILICON DIOXIDE

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

PURPOSE

Supplement

INDICATIONS & USAGE

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PRINCIPAL DISPLAY PANEL

product

ACTIVE INGREDIENT

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DOSAGE & ADMINISTRATION

 Calcium Carbonate 1250 mg Vitamin D3 250 IU

INGREDIENTS AND APPEARANCE

APCAL 
calcium carbonate and vitamin d3 tablet

Product 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)