Oyster Shell Calcium: Package Insert and Label Information

OYSTER SHELL CALCIUM- calcium carbonate tablet
Central Texas Community Health Centers

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).

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.

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.

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.

PRINCIPAL DISPLAY PANEL -- 500 mg Tablet Bottle Label
(click image for full-size original)
OYSTER SHELL CALCIUM
calcium carbonate tablet
Product Information
Product Type Item Code (Source) NDC:76413-322
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Calcium carbonate (CALCIUM CATION) CALCIUM CATION 500 mg
Inactive Ingredients
Ingredient Name Strength
Croscarmellose sodium
Microcrystalline Cellulose
HYPROMELLOSE, UNSPECIFIED
Polydextrose
Titanium Dioxide
Talc
Sodium Lauryl Sulfate
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 1mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76413-322-01 60 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
DIETARY SUPPLEMENT 04/01/2016
Labeler — Central Texas Community Health Centers (079674019)
Establishment
Name Address ID/FEI Operations
Central Texas Community Health Centers 079674019 REPACK, RELABEL
Establishment
Name Address ID/FEI Operations
Major Pharmaceuticals 383359612 MANUFACTURE

Revised: 09/2017 Central Texas Community Health Centers

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