- 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.