PRENATAL- Vitamin A, Ascorbic Acid, Cholecalciferol, .Alpha
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PRENATAL- vitamin a, ascorbic acid, cholecalciferol, .alpha.-tocopherol, thiamine, riboflavin, niacin, pyridoxine, folic acid, cyanocobalamin, calcium, ferrous fumarate, and zinc oxide tablet Central Texas Community Health Centers ---------- Prenatal Tablets Supplement Facts Serving Size: 1 Tablet % Daily Amount Per Serving Value* 4000 Vitamin A (as Acetate and Beta Carotene) 50% I.U. 100 Vitamin C (as Ascorbic Acid) 167% mg. 400 Vitamin D-3 (as Cholecalciferol) 100% I.U. Vitamin E (as dl-Alpha Tocopheryl Acetate) 11 I.U. 37% Vitamin B-1 (as Thiamine Mononitrate) 1.5 mg. 88% Vitamin B-2 (Riboflavin) 1.7 mg. 85% Vitamin B-3 (as Niacinamide) 18 mg. 90% Vitamin B-6 (as Pyridoxine HCl) 2.6 mg. 104% Folic Acid 0.8 mg. 100% Vitamin B-12 (as Cyanocobalamin) 4 mcg. 50% Calcium (as Calcium Carbonate and Calcium Sulfate) 263 mg. 26% Iron (as Ferrous Fumarate) 27 mg. 150% Zinc (as Zinc Oxide) 25 mg. 167% * % Daily Value for Pregnant and Lactating Women OTHER INGREDIENTS: Microcrystalline Cellulose, Stearic Acid, Hypromellose, Croscarmellose Sodium, Gelatin, Acacia, Maltodextrin, Titanium Dioxide, Talc, Triacetin, Starch, Magnesium Stearate, Dicalcium Phosphate, Mineral Oil, Sucrose, Silica, Sodium Ascorbate, Triglycerides, FD&C Red #40 Lake, FD&C Yellow #6 Lake, Tocopherols, Sodium Benzoate, Sorbic Acid, Tricalcium Phosphate, BHT and Ascorbyl Palmitate. 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. 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. FREE OF Yeast, wheat, milk or milk derivatives, soy, artificial flavor, sodium (less than 5 mg per serving). 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 M-29 Rev. 03/16 7434-03-16 PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label CommUnityCare Federally Qualified Health Centers PRENATAL VITAMINS # 100 Date: Name: Dr. TAKE 1 TABLET DAILY AS DIRECTED BY PHYSICIAN. 01/01/01 123456 PRENATAL VITAMINS #100TABS NDC 76413-315-01 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. PRENATAL vitamin a, ascorbic acid, cholecalciferol, .alpha.-tocopherol, thiamine, riboflavin, niacin, pyridoxine, folic acid, cyanocobalamin, calcium, ferrous fumarate, and zinc oxide tablet Product Information Product T ype DIETARY SUPPLEMENT Ite m Code (Source ) NHRIC:76 413-315 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Vita min A (UNII: 8 1G40 H8 B0 T) (Vitamin A - UNII:8 1G40 H8 B0 T) Vitamin A 40 0 0 [iU] Asco rbic Acid (UNII: PQ6 CK8 PD0 R) (Asco rbic Acid - UNII:PQ6 CK8 PD0 R) Asco rbic Acid 10 0 mg Cho leca lcifero l (UNII: 1C6 V77QF41) (Cho lecalcifero l - UNII:1C6 V77QF41) Cho lecalcifero l 40 0 [iU] .Alpha .-To co phero l (UNII: H4N8 55PNZ1) (.Alpha.-To co phero l - UNII:H4N8 55PNZ1) .Alpha.-To co phero l 11 [iU] Thia mine (UNII: X6 6 NSO3N35) (Thiamine Io n - UNII:4ABT0 J9 45J) Thiamine 1.5 mg Ribo fla vin (UNII: TLM29 76 OFR) (Ribo flavin - UNII:TLM29 76 OFR) Ribo flavin 1.7 mg Nia cin (UNII: 26 79 MF6 8 7A) (Niacin - UNII:26 79 MF6 8 7A) Niacin 18 mg Pyrido xine (UNII: KV2JZ1BI6 Z) (Pyrido xine - UNII:KV2JZ1BI6 Z) Pyrido xine 2.6 mg Fo lic a cid (UNII: 9 35E9 7BOY8 ) (Fo lic acid - UNII:9 35E9 7BOY8 ) Fo lic acid 0 .8 mg Cya no co ba la min (UNII: P6 YC3EG20 4) (Cyano co balamin - UNII:P6 YC3EG20 4) Cyano co balamin 4 ug Ca lcium (UNII: SY7Q8 14VUP) (Calcium - UNII:SY7Q8 14VUP) Calcium 26 3 mg Ferro us fuma ra te (UNII: R5L48 8 RY0 Q) (Ferro us catio n - UNII:GW8 9 58 1OWR) Ferro us catio n 27 mg Zinc o xide (UNII: SOI2LOH54Z) (Zinc o xide - UNII:SOI2LOH54Z) Zinc o xide 25 mg Inactive Ingredients Ingredient Name Strength Micro crysta lline cellulo se (UNII: OP1R32D6 1U) stea ric a cid (UNII: 4ELV7Z6 5AP) Hypro mello se, Unspecified (UNII: 3NXW29 V3WO) cro sca rmello se so dium (UNII: M28 OL1HH48 ) Gela tin, Unspecified (UNII: 2G8 6 QN327L) a ca cia (UNII: 5C540 3N26 O) ma lto dextrin (UNII: 7CVR7L4A2D) tita nium dio xide (UNII: 15FIX9 V2JP) ta lc (UNII: 7SEV7J4R1U) tria cetin (UNII: XHX3C3X6 73) ma g nesium stea ra te (UNII: 70 0 9 7M6 I30 ) Anhydro us Diba sic Ca lcium Pho spha te (UNII: L11K75P9 2J) minera l o il (UNII: T5L8 T28 FGP) sucro se (UNII: C151H8 M554) Silico n Dio xide (UNII: ETJ7Z6 XBU4) so dium a sco rba te (UNII: S0 33EH8 359 ) FD&C Red NO . 4 0 (UNII: WZB9 127XOA) FD&C Yello w NO . 6 (UNII: H77VEI9 3A8 ) Aluminum O xide (UNII: LMI26 O6 9 33) To co phero l (UNII: R0 ZB2556 P8 ) So dium Benzo a te (UNII: OJ245FE5EU) So rbic a cid (UNII: X0 45WJ9 8 9 B) Trica lcium Pho spha te (UNII: K4C0 8 XP6 6 6 ) Butyla ted Hydro xyto luene (UNII: 1P9 D0 Z171K) Asco rbyl Pa lmita te (UNII: QN8 3US2B0 N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:76 413-315-0 1 10 0 in 1 BOTTLE, PLASTIC Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date DIETARY SUPPLEMENT 0 3/0 1/20 16 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color scoring 1 shape size (solid drugs) 1 mm Labeler - Central T exas Community Health Centers (079674019) Establishment Name Addre ss ID/FEI Busine ss Ope rations Central Texas Co mmunity Health Centers 0 79 6 740 19 REPACK, RELABEL Establishment Name Addre ss ID/FEI Busine ss Ope rations Majo r Pharmaceuticals 38 3359 6 12 MANUFACTURE Revised: 9/2017 Central Texas Community Health Centers.