Oyster Shell Calcium (Calcium Carbonate) Tablet [Central Texas Community Health Centers] -

OYSTER SHELL CALCIUM (CALCIUM CARBONATE) TABLET [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]
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NDC	76413-322-01
Set ID	79a22a47-41c3-4b9b-8e9f-92b1b2999ba2
Category	DIETARY SUPPLEMENT
Packager	Central Texas Community Health Centers
Generic Name
Product Class
Product Number
Application Number

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STATEMENT OF IDENTITY

Supplement Facts
Serving Size: 1 Tablet
Amount Per Serving % Daily Value
Calcium (as Oyster Shell) 500 mg. 50%

OTHER INGREDIENTS: Croscarmellose Sodium, Microcrystalline Cellulose, Hypromellose, Polydextrose, Titanium Dioxide, Soy Polysaccharide, Talc, Sodium Lauryl Sulfate and Triglycerides.

Contains: Soy and Shellfish
DIRECTIONS

For adults, take one (1) tablet daily preferably with a meal. As a reminder, discuss the supplements and medications you take with your health care providers.
WARNING

If you are pregnant, nursing, taking any medications or planning any medical procedure, consult your doctor before use. Discontinue use and consult your doctor if any adverse reactions occur.
FREE OF

Yeast, wheat, milk or milk derivatives, lactose, sugar, preservatives, artificial color, artificial flavor, sodium (less than 5 mg per serving).
HEALTH CLAIM

Adequate calcium throughout life, as part of a well balanced diet, may reduce the risk of osteoporosis*

* THIS STATEMENT HAS NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE, OR PREVENT ANY DISEASE.
SAFE HANDLING WARNING

KEEP OUT OF THE REACH OF CHILDREN. STORE AT ROOM TEMPERATURE AND AVOID EXCESSIVE HEAT.

TAMPER RESISTANT: DO NOT USE IF SEAL UNDER CAP IS BROKEN OR MISSING.
HEALTH CLAIM

Distributed by: MAJOR® PHARMACEUTICALS
31778 Enterprise Drive, Livonia, MI 48150, USA
Questions or Comments? (800) 616-2471

LOT # & EXP. DATE:
M-29 Rev. 04/16
11098-04-16
PRINCIPAL DISPLAY PANEL - 500 mg Tablet Bottle Label

CommUnityCare Federally Qualified Health Centers

CALCIUM
CARB
TABS
500MG
#60

Date:

Name:
Dr.

TAKE AS DIRECTED BY PHYSICIAN.

01/01/01

123456

CALCIUM CARBONATE 500MG #60 TABS NDC 76413-322-01

Batch:
123456
Lot:
123456
Exp:
01/01/01

MAJOR

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

Supplement Facts
Calcium (as Oyster Shell)	500 mg.	50%

INGREDIENTS AND APPEARANCE

OYSTER SHELL CALCIUM
calcium carbonate tablet

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:76413-322
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Calcium carbonate (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	500 mg

Ingredient Name	Strength
Inactive Ingredients
Croscarmellose sodium (UNII: M28OL1HH48)
Microcrystalline Cellulose (UNII: OP1R32D61U)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
Polydextrose (UNII: VH2XOU12IE)
Titanium Dioxide (UNII: 15FIX9V2JP)
Talc (UNII: 7SEV7J4R1U)
Sodium Lauryl Sulfate (UNII: 368GB5141J)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NHRIC:76413-322-01	60 in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
DIETARY SUPPLEMENT		04/01/2016

	Amount Per Serving	% Daily Value
Supplement Facts
Serving Size :		Serving per Container :
color
scoring	1
shape
size (solid drugs)	1 mm

Labeler - Central Texas Community Health Centers (079674019)

Name	Address	ID/FEI	Business Operations
Establishment
Central Texas Community Health Centers		079674019	REPACK, RELABEL

Name	Address	ID/FEI	Business Operations
Establishment
Major Pharmaceuticals		383359612	MANUFACTURE

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Medic

OYSTER SHELL CALCIUM (CALCIUM CARBONATE) TABLET [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]

Related Drugs

Supplement Facts
Serving Size: 1 Tablet
Amount Per Serving	% Daily Value
Calcium (as Oyster Shell)	500 mg.	50%