TENDERA-OB- ascorbic acid, cholecalciferol, .alpha.-tocopherol, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, levomefolate glucosamine, cyanocobalamin, iron pentacarbonyl, potassium iodide, magnesium oxide, zinc gluconate, cupric oxide, and doconexent capsule 
BonGeo Pharmaceuticals, Inc.

----------

Tendera-OB Prenatal Multivitamin + DHA

Supplement Facts
Serving Size: 1 SoftgelServings Per Container: 90
Amount Per Serving% Daily Value in Pregnancy
*
Daily Value not established.
Vitamin C (as Ascorbic Acid)40 mg67%
Vitamin D (as Cholecalciferol)1000 IU250%
Vitamin E (as d-Alpha- Tocopheryl Acetate)10 IU33%
Vitamin B1 (as Thiamine Mononitrate)1.5 mg88%
Vitamin B2 (as Riboflavin)2 mg100%
Vitamin B3 (as Niacin)12 mg60%
Vitamin B6 (as Pyridoxine HCl)3 mg120%
Folate (as 400 mcg Quatrefolic R ((6S-5-meth-yltetrahydrofolic acid, glucosamine salt, molar equivalent to 216 mcg of folic acid)) and 784 mcg of folic acid)1 mg125%
Vitamin B12 (as Cyanocobalamin 1%)15 mcg188%
Iron (as Iron Carbonyl Powder)27 mg150%
Iodine (as Potassium Iodide)150 mcg100%
Magnesium (as Magnesium Oxide)10 mg3%
Zinc (as Zinc Gluconate)5 mg33%
Copper (as Copper Oxide)1 mg50%
Docosahexaenoic Acid (DHA, Omega-3 Fish Oil)205 mg*

OTHER INGREDIENTS: Gelatin capsule (bovine gelatin, glycerin, purified water, Annatto and Caramel), yellow beeswax, sunflower, lecithin. Contains: Fish.

Tendera-OB™ Softgel capsules are dye free, lactose, gluten and sugar free. They do not contain any artificial flavors or sweeteners.

INDICATIONS

Tendera-OB™ is an orally administered multivitamin/multimineral fatty acid dietary supplement indicated to improve the nutritional status of women during pregnancy and in the postnatal period for both breastfeeding and non-breastfeeding mothers. Tendera-OB™ may also be beneficial in improving the nutritional status of women prior to conception.

CONTRAINDICATIONS

Tendera-OB™ is contraindicated in patients with a known hypersensitivity to any of the ingredients.

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6.
Keep this product out of reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately.

Caution is recommended in patients taking anticonvulsant medications as folate may interfere with anticonvulsant medication, and may lower seizure threshold. Decreased patient response to methotrexate may occur due to supplementation of folic acid. Furthermore, anticonvulsant medications may interfere with folate metabolism.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent disease.

PRECAUTIONS

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding. Supplemental intake of omega 3 fatty acids such as DHA above 2 grams per day is not recommended. In individuals with hypercalcemia or other conditions that may lead to hypercalcemia such as hyperparathyroidism and those that form calcium- containing kidney stones, Vitamin D supplementation should be used with caution. Elevated levels of calcium in blood and soft tissues may result from high doses of Vitamin D.

Use caution supplementing iodine in patients with overactive thyroid.

ADVERSE REACTIONS

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact BonGeo Pharmaceuticals, Inc. at 1-844-640-7607.

DIRECTIONS

Adults

Take one softgel daily with or without food, or as prescribed by a healthcare practitioner.

Not recommended for children under 12 years of age.

Do not exceed the recommended dose.

Tendera-OB™ should be administered under the direct supervision of a qualified healthcare practitioner.

HOW SUPPLIED

Tendera-OB™ is available as oval, dark red softgel capsules with an imprint "190". They are available in child-resistant bottles containing 90 softgels (52796-190-90). Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.]

Avoid excessive heat, light and moisture.

Keep out of reach of children.

Tamper Evident

Do not use if seal is broken or missing.

LOT

EXP

Manufactured for: BonGeo Pharmaceuticals, Inc.,
101 Eisenhower Parkway, Ste. 300 Roseland, NJ 07068
1-844-640-7607 | www.bongeopharma.net

PRINCIPAL DISPLAY PANEL - 90 Softgel Bottle Label

52796-190-90
90 SOFTGELS

Tendera-OB
Prenatal Multivitamin + DHA
DIETARY SUPPLEMENT

Quatrefolic®
Patent Ref.: U.S. Patent No. 7,947,662;
Other patents pending

Sugar Free,
Lactose Free and
Gluten Free

No Artificial Colors
or Flavors

BonGeo
PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL - 90 Softgel Bottle Label
TENDERA-OB 
ascorbic acid, cholecalciferol, .alpha.-tocopherol, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, levomefolate glucosamine, cyanocobalamin, iron pentacarbonyl, potassium iodide, magnesium oxide, zinc gluconate, cupric oxide, and doconexent capsule
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:52796-190
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID40 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL1000 [iU]
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL10 [iU]
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.5 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN2 mg
NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN12 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE3 mg
LEVOMEFOLATE GLUCOSAMINE (UNII: Q65PL71Q1A) (LEVOMEFOLATE GLUCOSAMINE - UNII:Q65PL71Q1A) LEVOMEFOLATE GLUCOSAMINE1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN15 ug
IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION27 mg
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE150 ug
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE10 mg
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE5 mg
CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION1 mg
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT205 mg
Inactive Ingredients
Ingredient NameStrength
glycerin (UNII: PDC6A3C0OX)  
water (UNII: 059QF0KO0R)  
annatto (UNII: 6PQP1V1B6O)  
caramel (UNII: T9D99G2B1R)  
yellow wax (UNII: 2ZA36H0S2V)  
helianthus annuus whole (UNII: 17S27ZT6KR)  
fish, unspecified (UNII: 1PIO77PW2X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:52796-190-9090 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT03/19/2019
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
scoring1
shape
size (solid drugs)15 mm
imprint
Labeler - BonGeo Pharmaceuticals, Inc. (964822022)

Revised: 3/2019
Document Id: 522e6a96-f13f-4824-ad9f-510d4e6381ef
Set id: 4f09a0d6-24f4-475c-bf90-853c0e210025
Version: 1
Effective Time: 20190319
 
BonGeo Pharmaceuticals, Inc.