Healthy Mama Prenatal Vitamins

Healthy Mama Prenatal Vitamins
SPL v2
SPL
SPL Set ID b0addefd-148c-423b-bcff-332c255a2d90
Route
ORAL
Published
Effective Date 2013-07-09
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
.beta.-carotene (4000 [iU]) Ascorbic Acid (120 mg) Cholecalciferol (400 [iU]) Alpha-tocopherol, Dl- (30 [iU]) Thiamine Ion (1.8 mg) Riboflavin (1.7 mg) Niacin (20 mg) Pyridoxine (2.6 mg) Folic Acid (800 ug) Methylcobalamin (8 ug) Calcium Cation (200 mg) Ferrous Cation (28 mg) Zinc Cation (25 mg) Copper (2 mg) Biotin (30 ug) Pantothenic Acid (10 mg) Magnesium Cation (30 mg)
Inactive Ingredients
Ascorbyl Palmitate Croscarmellose Sodium Calcium Phosphate, Dibasic, Anhydrous Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Hypromelloses Magnesium Stearate Maltodextrin Cellulose, Microcrystalline .alpha.-tocopherol Starch, Corn Propylene Glycol Silicon Dioxide Sodium Ascorbate Sodium Benzoate Sorbic Acid Stearic Acid Sucrose Sunflower Oil Titanium Dioxide Triacetin

Identifiers & Packaging

Pill Appearance
Imprint: NA Shape: oval Color: yellow Size: 7 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2013-07-09

Description

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                      


Medication Information

Indications and Usage

PRENATAL VITAMINS



Description

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                      

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.

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)



Precautions

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

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.



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

                     



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

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.com


Structured Label Content

Indications and Usage (34067-9)

PRENATAL VITAMINS



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.

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)



Precautions

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

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.



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

                     



Other Information (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

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.com


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