EDGE OB
-
beta carotene,
ascorbic acid,
cholecalciferol,
.alpha.-tocopherol acetate, dl-,
thiamine mononitrate,
riboflavin,
niacinamide,
pyridoxine hydrochloride,
folic acid,
cyanocobalamin,
iron,
magnesium oxide and
zinc oxide tablet
River’s Edge Pharmaceuticals, LLC
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Edge OBDESCRIPTION:
Supplement FactsServing Size: 1 Caplet
Amount Per Serving % Daily Value
Vitamin A (as acetate and beta carotene) 1700 IU 34% DV
Vitamin C (as ascorbic acid) 60 mg 100% DV
Vitamin D3 (cholecalciferol) 400 IU 100% DV
Vitamin E (as dl-alpha tocopheryl acetate) 30 IU 100% DV
Vitamin B1 (as thiamine mononitrate) 1.6 mg 107% DV
Vitamin B2 (riboflavin) 1.8 mg 106% DV
Niacin (as niacinamide) 15 mg 75% DV
Vitamin B6 (as pyridoxine hydrochloride) 2.5 mg 125% DV
Folic Acid 1 mg 250% DV
Vitamin B12 (cyanocobalamin) 5 mcg 83% DV
Iron (as polysaccharide iron complex) 29 mg 161% DV
Magnesium (as magnesium oxide) 25 mg 6% DV
Zinc (as zinc oxide) 15 mg 100% DV
Other Ingredients: Dicalcium Phosphate, Fructose, Mono/Diglycerides, Croscarmellose Sodium, Hydroxypropyl Methylcellulose, Magnesium Stearate, Stearic Acid, Citric Acid, Titanium Dioxide, Natural and Artificial Mouthfeel Flavor, Silicon Dioxide, Polydextrose, Maltodextrin, Triacetin, Wildberry Flavor NAT WONF Spray Dried, Malic Acid, Cornstarch, Sucrose, Starch, Gelatin, Sodium Citrate, Polyethylene Glycol, Polysorbate 80, D and C Yellow 10 Aluminum Lake, FD and C Yellow 6 Aluminum Lake, Hydrogenated Soybean Oil, Ascorbyl Palmitate, dl-alpha Tocopherol, Sodium Ascorbate, Gum Arabic, BHT.
Contains NO preservatives, yeast, wheat, gluten, nuts or milk-based by-products.
INDICATIONS AND USAGE:
Edge OB is indicated to provide vitamin and mineral supplementation throughout pregnancy and during postnatal period for the lactating and non-lactating mother. It is also useful for improving the nutritional status prior to conception.
Edge OB: Contains 1 mg of folic acid, which is important in the development of the baby’s brain and spinal cord, particularly during the first trimester of pregnancy.
Women are advised to start taking folate supplementation several weeks before conception and to continue taking them through the first 12 weeks of pregnancy, or longer. It is recommended that all women of childbearing years take folic acid supplementation.
CONTRAINDICATIONS:
Folic acid (pteroylglutamic acid) is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid. Iron therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia, pyridoxine responsive anemia, or cirrhosis of the liver. Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (Vitamin B12). Resistance to treatment may be due to depressed hematopoiesis, alcoholism, the presence of anti-metabolites and vitamin deficiencies. Prolonged use of iron salts may produce iron storage disease.
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.
WARNINGS:
Pernicious anemia should be ruled out before starting treatment. While folic acid corrects the hematological profile of pernicious anemia, it does not ameliorate the underlying neurologic involvement.
PRECAUTIONS:
Folic acid especially in doses above 0.1 mg daily, may mask pernicious anemia, in that hematologic remission may occur while neurological manifestations continue to progress.
ADVERSE REACTIONS:
Allergic sensitivity reactions and gastrointestinal disturbances may occur.
Call your doctor for medical advice about side effects. You may report suspected side effects to the FDA at 1-800-FDA-1088.
DOSAGE AND ADMINISTRATION:
Before, during and after pregnancy, chew or swallow one caplet daily, or as directed by a physician.
HOW SUPPLIED:
Edge OB is available as a yellow capsule-shaped caplet that can be CHEWED or SWALLOWED, imprinted “RE 322”: bottles of 90 caplets NDC 68032-322-90. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure. Store at controlled room temperature 15°-30°C (59°- 86°F). Keep in a cool, dry place.
WARNING: Keep this and all drugs out of reach of children.
Caution: Rx Only
Manufactured for:
River’s Edge Pharmaceuticals, LLC
Suwanee, GA 30024
322-11
Iss. 10/08
PRINCIPAL DISPLAY PANEL
NDC 68032-322-90Rx Only
Edge OB
Prenatal Multivitamin and Minerals
Store at controlled room temperature 15°–30°C (59°–86°F).
Keep in a cool, dry place.
Mfd. For: River’s Edge Pharmaceuticals, LLC
Suwanee, GA 30024
Dietary Supplement
90 Caplets
| EDGE OB
beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, iron, magnesium oxide, zinc oxide tablet |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | 10/01/2008 | 11/16/2010 | |
| Labeler - River’s Edge Pharmaceuticals, LLC (133879135) |