Tendera-OB Prenatal Multivitamin + DHA

Basic Information

Product Label

Product label for Tendera-OB Prenatal Multivitamin + DHA
Full Name: Tendera-OB Prenatal Multivitamin + DHA
Brand: BonGeo Pharmaceuticals
Product Type: Other Combinations
Physical State: Softgel Capsule
UPC/SKU: 3 52796 19090 9
Product Version Code: Not Present

Contact Information

Manufactured for

Name: BonGeo Pharmaceuticals, Inc.
Address:101 Eisenhower Parkway, Ste. 300, Roseland, NJ, 07068
Phone: 1-844-640-7607
Website: www.bongeopharma.net
Types: Distributor

Product Details

Net Contents

90 Softgel(s)(90 Softgel(s))

Serving Sizes

Unit:Softgel(s)
Quantity:1 - 1
Daily Servings:1 - 1

Target Groups

Pregnant WomenAdult Female (18 - 50 Years)LactatingGluten FreeSugar Free

Servings Per Container

90

Ingredients & Nutrition

Copper

mineral
Forms:
  • Copper Oxide
Amount: 1 mg
Serving Size: 1 Softgel(s)
Pregnant and Lactating: 50%

Group: Copper

Notes: Omega-3 Fish Oil

Forms:
  • Fish Oil
Amount: 205 mg
Serving Size: 1 Softgel(s)
Pregnant and Lactating: % (Daily Value not established)

Group: DHA (Docosahexaenoic Acid)

Also known as: DHA

Folate

vitamin
Amount: 1 mg
Serving Size: 1 Softgel(s)
Pregnant and Lactating: 125%

Group: Vitamin B9 (Folate)

Iodine

mineral
Forms:
  • Potassium Iodide
Amount: 150 mcg
Serving Size: 1 Softgel(s)
Pregnant and Lactating: 100%

Group: Iodine

Iron

mineral
Forms:
  • Iron Carbonyl, Powder
Amount: 27 mg
Serving Size: 1 Softgel(s)
Pregnant and Lactating: 150%

Group: Iron

Magnesium

mineral
Forms:
  • Magnesium Oxide
Amount: 10 mg
Serving Size: 1 Softgel(s)
Pregnant and Lactating: 3%

Group: Magnesium

Vitamin B1

vitamin
Forms:
  • Thiamine Mononitrate
Amount: 1.5 mg
Serving Size: 1 Softgel(s)
Pregnant and Lactating: 88%

Group: Thiamin

Also known as: Thiamin, Thiamine

UNII Code: X66NSO3N35

Notes: 1% Cyanocobalamin

Forms:
  • Cyanocobalamin
Amount: 15 mcg
Serving Size: 1 Softgel(s)
Pregnant and Lactating: 188%

Group: Vitamin B12

UNII Code: 8406EY2OQA

Vitamin B2

vitamin
Forms:
  • Riboflavin
Amount: 2 mg
Serving Size: 1 Softgel(s)
Pregnant and Lactating: 100%

Group: Vitamin B

Vitamin B3

vitamin
Forms:
  • Niacin
Amount: 12 mg
Serving Size: 1 Softgel(s)
Pregnant and Lactating: 60%

Group: Niacin

Also known as: IP-6

UNII Code: 2679MF687A

Vitamin B6

vitamin
Forms:
  • Pyridoxine Hydrochloride
Amount: 3 mg
Serving Size: 1 Softgel(s)
Pregnant and Lactating: 120%

Group: Vitamin B6

Vitamin C

vitamin
Forms:
  • Ascorbic Acid
Amount: 40 mg
Serving Size: 1 Softgel(s)
Pregnant and Lactating: 67%

Group: Vitamin C (unspecified)

Vitamin D

vitamin
Forms:
  • Cholecalciferol
Amount: 1000 IU
Serving Size: 1 Softgel(s)
Pregnant and Lactating: 250%

Group: Vitamin D

Vitamin E

vitamin
Forms:
  • D-Alpha-Tocopheryl Acetate
Amount: 10 IU
Serving Size: 1 Softgel(s)
Pregnant and Lactating: 33%

Group: Vitamin E

Also known as: Sun E 900, Naturall-e, Sunvitol, Sunvitol E500, Delta Gold Tocotrienol

UNII Code: H4N855PNZ1

Zinc

mineral
Forms:
  • Zinc Gluconate
Amount: 5 mg
Serving Size: 1 Softgel(s)
Pregnant and Lactating: 33%

Group: Zinc

Group: Vitamin B9 (5-Methyltetrahydrofolate)

Also known as: Quatrefolic

Group: Vitamin B9 (5-Methyltetrahydrofolate)

Annatto

botanical

Group: Annatto

Group: Gelatin

Caramel

other

Group: Flavor

Folacin

vitamin

Group: Vitamin B9 (folic acid)

Also known as: Folic Acid

Folic Acid

vitamin

Group: Folate

Also known as: Orgen-FA, Vitamin B9, Quatrefolic, Folacin, CitraFolic, B9, Folate

UNII Code: 935E97BOY8

Glucosamine Salt

non-nutrient/non-botanical

Group: Glucosamine (unspecified)

Group: Glycerol

Group: lecithin

life’s DHA

fatty acid

Group: DHA (Docosahexaenoic Acid)

Also known as: Docosahexaenoic Acid

Group: Vitamin B3 (Niacin)

Also known as: Vitamin B3

UNII Code: 2679MF687A

Group: Vitamin B6 (pyridoxine)

Also known as: Vitamin B6

Group: Vitamin B2 (Riboflavin)

Also known as: Vitamin B2

Group: Vitamin B1 (Thiamine)

Also known as: Vitamin B1

Quali-C

vitamin

Group: Vitamin C (ascorbic acid)

Also known as: Vitamin C

Quatrefolic

non-nutrient/non-botanical

Group: 5-methyltetrahydrofolate glucosamine

Also known as: (6S)-5-Methylfolate, (6S)-5-MTHF

UNII Code: Q65PL71Q1A

Sunflower

botanical

Group: sunflower

UNII Code: BKJ0J3D1BP

Vitamin B9

vitamin

Group: Folate

Also known as: Folic Acid, Folate

UNII Code: 935E97BOY8

Group: Water

UNII Code: 059QF0KO0R

yellow Beeswax

animal part or source

Group: Beeswax

Product Statements

General Statements: All Other Content

52796-190-90

FDA Statement of Identity

Dietary Supplement

Formula re: Contains

Quatrefolic

Brand IP Statement(s) re: (c), (TM), (SM)

Quatrefolic Patent ref.: U.S. patent no. 7,947,662; Other patents pending

Formulation re: Does NOT Contain

Sugar free, lactose free and gluten free No artificial colors or flavors

Precautions re: Allergies

Contains: Fish.

Formulation re: Does NOT Contain

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

Formulation re: Other

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.

Formula re: Type

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.

Precautions re: All Other

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

Precautions re: Children

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.

Precautions re: Pregnant or Nursing or Prescription Medications

Caution is recommended is 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.

FDA Disclaimer Statement

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 re: All Other

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.

Precautions re: All Other

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). Supplemental intake of omega 3 fatty acids such as DHA above 2 grams per day in 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.

Precautions re: Allergies

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

Suggested/Recommended/Usage/Directions

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

Precautions re: Children

Not recommended for children under 12 years of age.

Precautions re: All Other

Do not exceed the recommended dose. Tendera-OB should be administered under the direct supervision of a qualified healthcare practitioner.

Formulation re: Other

How supplied Tender-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).

Storage

Store at 20 degrees-25 degrees C (68 degrees-77 degrees F); excursions permitted to 15 degrees-30 degrees C (59 degrees-86 degrees F) [See USP controlled room temperature.] Avoid excessive heat, light and moisture.

Precautions re: Children

Keep out of reach of children.

Precautions re: All Other

Tamper evident Do not use if seal is broken or missing.

Precautions re: Pregnant or Nursing or Prescription Medications

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.

Precautions re: All Other

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.

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