Label: HEALTHY MAMABE WELL ROUNDED BE WELL ROUNDED- .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine, riboflavin, niacin, pyridoxine hydrochloride, folic acid, methylcobalamin, calcium carbonate, ferrous bisglycinate, zinc oxide, copper, calcium pantothenate,magnesium oxide tablet, film coated

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated July 9, 2013

If you are a consumer or patient please visit this version.

  • BOXED WARNING(What is this?)

    Warning

    Warning: Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under age 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

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  • Supplement Facts

    Serving Size: 1 caplet

    Serving per Container: 60

                                                                    Annual Per Serving          % DV*

    Vitamin A ( as beta Carotene)                          4000IU                        50%

    Vitamin C ( as Ascorbic Acid)                           120mg                        200%

    Vitamin D3 ( as Cholecalciferol)                          400IU                        100%

    Vitamin E( from dl-Alpha Tocopheryl Acetate)       30IU                         100%

    Thiamin (B1)                                                     1.8mg                        108%

    Riboflavin                                                         1.7mg                          85%

    Niacin (B3)                                                        20mg                        100%

    Vitamin B6 (from Pyridoxine Hydrocholride)         2.6mg                        104%

    Folic Acid                                                       800mcg                      100%

    Vitamin B12(as Methylcobalamin)                        8mcg                      100%

    Biotin                                                              30 mcg                      10%

    Pantothenic Acid( d-Calcium Patothenate)           10 mg                       100%

    Calcium( from Calcium Carbonate)                    200 mg                         15%

    iron(Ferrous Bisglycinate Chelate)                      28 mg                        156%

    Magnesium ( from Chelate and oxide)                30 mg                            8%

    Zinc ( from Zinc Oxide)                                     25 mg                         167%

    Copper (from Chelate)                                        2 mg                         100%

    % Daily value9DV) for pregnant and lactating women

    Other ingredients: Microcrystalline cellulose, croscarmellose sodium, stearic acid, gelatin, corn starch, maltodextrin, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide , sunflower oil, dicalcium phosphate dihydrate, sucrose, Ascorbyl palmitate, dl-alpha tocopherol, sodium ascorbate, FD and C Red #40, red oxide, triglycerides, sodium benzoate, FD and C Yellow # 6, sorbic acid, propylene glycol, triacetin

                         


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  • INDICATIONS & USAGE

    PRENATAL VITAMINS


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  • Suggested Use

    Adults-take one caplet daily with water, preferably with a mean, as a dietary supplement, or as directed by doctor. As with any supplement if you are pregnent, nursing, or taking medication.consult your doctor before use.


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  • Precautions

    Folic Acid may partially correct the hematological damage due to vitamin B12 deficiency of pernicious anemia, while the associated neurological damage progresses.

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  • Other information

    Store at a room temperature.

    • Keep lid tightly closed in a dry place
    • Do not use if imprinted safety seal under cap is broken or missing
    • keep out of reach of children
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  • Questions?

    If you have any questions or comments, or to report an adverse event, please contact 1-855-preg-i-am(1-855-773-4426)


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  • Principal Display Panel

    American Pregnancy Association

    healthy mama

    BE WELL ROUNDED!

    easy to swallow

    PRENATAL VITAMINS

    60 caplets

    DISTRIBUTED BY:

    Maternal Science, Inc

    50 Tice Blvd, Ste 340, woodcliff Lake ,Nj 07677

    www.healthymamabrand.comUntitledd.jpg

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  • INGREDIENTS AND APPEARANCE
    HEALTHY MAMABE WELL ROUNDED   BE WELL ROUNDED
    .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine, riboflavin, niacin, pyridoxine hydrochloride, folic acid, methylcobalamin, calcium carbonate, ferrous bisglycinate, zinc oxide, copper, calcium pantothenate,magnesium oxide tablet, film coated
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58154-107
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    .BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J) .BETA.-CAROTENE 4000 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 120 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 400 [iU]
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (ALPHA-TOCOPHEROL, DL- - UNII:7QWA1RIO01) ALPHA-TOCOPHEROL, DL- 30 [iU]
    THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 1.8 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 1.7 mg
    NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN 20 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 2.6 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 800 ug
    METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W) METHYLCOBALAMIN 8 ug
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 200 mg
    FERROUS BISGLYCINATE (UNII: SFW1D987QV) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 28 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 25 mg
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER 2 mg
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN 30 ug
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID 10 mg
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE 30 mg
    Inactive Ingredients
    Ingredient Name Strength
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBIC ACID (UNII: X045WJ989B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Color yellow (TAN - YELLOW) Score no score
    Shape OVAL Size 7mm
    Flavor Imprint Code NA
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58154-107-60 60 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 07/09/2013
    Labeler - MATERNAL SCIENCE, LLC (078722406)
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