Product Information

Form
Other (e.g. tea bag)
Servings Per Container
100
UPC
3 13811 02710 5
Product Type
Multi-Vitamin and Mineral (MVM)
DSLD Entry Date
2023-01-23

Target Groups

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

All Ingredients

IngredientAmount% DV
Vitamin A630 mcg RAE48%
Vitamin C120 mg100%
Vitamin D8 mcg53%
Vitamin E13 mg68%
Thiamin2 mg143%
Riboflavin3.4 mg213%
Niacin10 mg NE56%
Vitamin B610 mg500%
Folate2083 mcg DFE347%
Vitamin B1215 mcg536%
Pantothenic Acid5 mg71%
Iron50 mg185%
Magnesium15 mg4%
Zinc10 mg77%
Copper1 mg77%

† Daily Value not established.

Label Statements

Formulation re: Does NOT Contain

Gluten, sugar, and lactose-free

Formula re: Type

Elite OB is a prescription multivitamin/multimineral indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and non-lactating mothers.

Precautions re: Allergies

Contraindications Elite OB should not be used by patients with a known hypersensitivity to any of the listed 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: All Other

Precautions Folic acid alone is an 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 remain progressive.

Precautions re: Allergies

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

Precautions re: Pregnant or Nursing or Prescription Medications

The patient's medical conditions and consumption of other drugs, herbs, and/or supplements should be considered. Drug Interactions Elite OB caplets are not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin, Clopidogrel).

Precautions re: All Other

Adverse Reactions Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients.

Precautions re: Allergies

Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels.

General Statements: All Other Content

Description Elite OB is a pink capsule shaped caplet imprinted with "VP 010".

Suggested/Recommended/Usage/Directions

Directions For Use Take one caplet by mouth daily or as directed by a physician.

General Statements: All Other Content

How Supplied Elite OB is available in a unit dose pack of 100 (10x10) caplets. Product Code: 13811-027-10

Storage

Storage Store at controlled room temperature 15 degrees - 30 degrees C (59 degrees - 86 degrees F). [See USP]. Protect from light and moisture and avoid excessive heat.

Precautions re: Children

Keep this product out of reach of children.

General Statements: All Other Content

For use on the order of a healthcare practitioner.

Precautions re: All Other

Call your doctor about side effects. To report side effects, call Vertical Pharmaceuticals at 1-770-509-4500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

General Statements: All Other Content

13811-027-10

FDA Statement of Identity

Prenatal Multivitamin

Supplement Facts Panel

Supplement Facts
Serving Size 1 Caplet(s)
Servings Per Container 100
Amount Per Serving% Daily Value*
Vitamin A
630 mcg RAE48%
Vitamin C
120 mg100%
Vitamin D
8 mcg53%
Vitamin E
13 mg68%
Thiamin
2 mg143%
Riboflavin
3.4 mg213%
Niacin
10 mg NE56%
Vitamin B6
10 mg500%
Folate
2083 mcg DFE347%
Vitamin B12
15 mcg536%
Pantothenic Acid
5 mg71%
Iron
50 mg185%
Magnesium
15 mg4%
Zinc
10 mg77%
Copper
1 mg77%

* Percent Daily Values are based on a 2,000 calorie diet.

† Daily Value not established.

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