Animal Shapes W/Iron Chewtabs: Package Insert and Label Information

ANIMAL SHAPES W/IRON CHEWTABS- vitamin a, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine, folic acid, cyanocobalamin and ferrous fumarate tablet, chewable
Central Texas Community Health Centers

Supplement Facts
Serving Size: ½ Tablet (2-3 years of age)
1 Tablet (4 years of age & older)
Amount Per Tablet %DV * %DV
*
% Daily Value (DV) for Children 2-3 years of age (½ tablet).
%Daily Value (DV) for Adults and Children 4 or more years of age (1 tablet).
% Daily Value (DV) not established.
Vitamin A (as Acetate & Beta Carotene) 3,000 I.U. 60% 60%
Vitamin C (as Sodium Ascorbate) 60 mg. 75% 100%
Vitamin D-3 (as Cholecalciferol) 600 I.U. 75% 150%
Vitamin E (as dl-Alpha Tocopheryl Acetate) 30 I.U. 150% 100%
Vitamin K (as Phytonadione) 55 mcg. 69%
Vitamin B-1 (as Thiamine Mononitrate) 1.5 mg. 107% 100%
Vitamin B-2 (Riboflavin) 1.7 mg. 106% 100%
Niacinamide (Vitamin B-3) 15 mg. 83% 75%
Vitamin B-6 (as Pyridoxine HCl) 2 mg. 143% 100%
Folic Acid 0.4 mg. 100% 100%
Vitamin B-12 (as Cyanocobalamin) 6 mcg. 100% 100%
Biotin 40 mcg. 13% 13%
Pantothenic Acid (as Calcium Pantothenate) 10 mg. 100% 100%
Calcium (as Calcium Carbonate) 100 mg. 6% 10%
Iron (as Ferrous Fumarate) 18 mg. 90% 100%
Iodine (as Potassium Iodide) 150 mcg. 107% 100%
Zinc (as Zinc Oxide) 12 mg. 75% 80%
Copper (as Cupric Oxide) 2 mg. 100% 100%
Sodium (as Sodium Ascorbate) 21 mg. <1%

OTHER INGREDIENTS: Sorbitol, Sugar, Gelatin, Citric Acid, Stearic Acid, Starch, Cherry Flavor, Orange Flavor, Grape Flavor, Silica, Mannitol, Dicalcium Phosphate, Maltodextrin, Microcrystalline Cellulose, Magnesium Stearate, FD&C Red #40 Lake, FD&C Yellow #6 Lake, Sodium Ascorbate, FD&C Blue #2 Lake, Triglycerides, Tocopherols, Sodium Benzoate, Sorbic Acid, Tricalcium Phosphate, Ascorbyl Palmitate and BHT. Cherry flavor contains: Modified Corn Starch Grape flavor contains: Maltodextrin, Modified Corn Starch and Silica Orange flavor contains: Maltodextrin, Lactose 1, Natural Flavoring, Modified Corn Starch and Sugar


1
Contains: Milk

DIRECTIONS

Adults and children 4 years of age and older, chew one (1) tablet daily, preferably with a meal. For children, 2-3 years of age, chew one-half (1/2) tablet daily. 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. THIS PRODUCT IS INTENDED FOR USE BY CHILDREN UNDER ADULT SUPERVISION.

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under six. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or Poison Control Center immediately.

KEEP OUT OF THE REACH OF CHILDREN. STORE IN A DRY PLACE AND AVOID EXCESSIVE HEAT. TAMPER RESISTANT: DO NOT USE IF SEAL UNDER CAP IS BROKEN OR MISSING.

This product is not manufactured or distributed by Bayer, owner of the registered trademark Flintstones™ Complete.

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

M-29
10861-07-16
Rev. 07/16

PRINCIPAL DISPLAY PANEL — 100 Tablet Bottle Label

Austin/Travis Co. Health & Human Services Dept.

MVI w/Iron
Animal
Shapes
#100

Date:

Name: Dr.

Take as directed on package.

01/01/01

123456

MVI w/Iron Animal Shapes #100 NDC 76413-338-01

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 -- 100 Tablet Bottle Label
(click image for full-size original)
ANIMAL SHAPES W/IRON CHEWTABS
vitamin a, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine, folic acid, cyanocobalamin, and ferrous fumarate tablet, chewable
Product Information
Product Type Item Code (Source) NDC:76413-338
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Vitamin A (Vitamin A) Vitamin A 2500 [iU]
Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 60 mg
Cholecalciferol (Cholecalciferol) Cholecalciferol 400 [iU]
.Alpha.-Tocopherol Acetate, dl- (.Alpha.-Tocopherol, dl-) .Alpha.-Tocopherol, dl- 15 [iU]
Thiamine Mononitrate (Thiamine Ion) Thiamine 1.05 mg
Riboflavin (Riboflavin) Riboflavin 1.2 mg
Niacinamide (Niacinamide) Niacinamide 13.5 mg
Pyridoxine (Pyridoxine) Pyridoxine 1.05 mg
Folic acid (Folic acid) Folic acid 300 ug
Cyanocobalamin (Cyanocobalamin) Cyanocobalamin 4.5 ug
Ferrous fumarate (Ferrous Cation) Ferrous Cation 15 mg
Inactive Ingredients
Ingredient Name Strength
Sucrose
Dextrose, Unspecified Form
Stearic acid
Gelatin, Unspecified
magnesium stearate
anhydrous dibasic calcium phosphate
silicon dioxide
FD&C Red No. 40
Aluminum Oxide
FD&C Yellow No. 6
sodium ascorbate
FD&C Blue No. 2
Tocopherol
Sodium Benzoate
Sorbic acid
Butylated Hydroxytoluene
Product Characteristics
Color ORANGE, PINK, PURPLE Score no score
Shape FREEFORM (Animal) Size 1mm
Flavor CHERRY, ORANGE, GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76413-338-01 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
DIETARY SUPPLEMENT 03/01/2010
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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