Sulton

Sulton may be available in the countries listed below.

Ingredient matches for Sulton

Calcium Folinate

Calcium Folinate pentahydrate (a derivative of Calcium Folinate) is reported as an ingredient of Sulton in the following countries:

• Italy

International Drug Name Search

Dormilam

Dormilam may be available in the countries listed below.

Ingredient matches for Dormilam

Zolpidem

Zolpidem tartrate (a derivative of Zolpidem) is reported as an ingredient of Dormilam in the following countries:

• Chile

International Drug Name Search

Omeprazol Basics

Omeprazol Basics may be available in the countries listed below.

Ingredient matches for Omeprazol Basics

Omeprazole

Omeprazole is reported as an ingredient of Omeprazol Basics in the following countries:

• Germany

International Drug Name Search

Reaphirm Plant Source DHA

Dosage Form: capsule, gelatin coated
Product Information.

Contraindications

Reaphirm Plant Source DHA is contraindicated in patients with hypersensitivity to any of its components or color additives.

Folic 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 (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis of the liver.

Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (Vitamin B12).

Refer to MM1carton label

Boxed Warning

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

WARNINGS/PRECAUTIONS:

Reaphirm Plant Source DHA should be used with caution in patients with known sensitivity or allergy to soy.


Vitamin D supplementation should be used with caution in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kigney stones.  High doses of vitamin D can lead to elevated levels of calcium that reside in the blood and soft tissues.  Bone pain, high blood pressure, formation of kidney stones, renal failure, and increased risk of heart disease can occur.


Iodine should be used with caution in patients with an overactive thyroid.


Prolonged use of iron salts may produce iron storage disease.


Folic acid, especially in doses above 0.1 mg daily, may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive.


The use of folic acid doses above 1 mg daily may precipitate or exacerbate the neurological damage of vitamin B12 deficiency.


Consumption of more than 3 grams of omega-3 fatty acids per day from all sources may lead to excessive bleeding.  Supplemental intake of omega-3 fatty acids such as DHA exceeding 2 grams per day is not recommended.


Avoid Overdosage.  Keep out of the reach of children.


Drug Interactions:


Medications for an overactive thyroid (anti-thyroid drugs) used in conjunction with iodine supplementation may lead to hypothyroidism.


Medications for hypertension used in conjunction with iodine supplementation may increase potassium.


High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs.


Vitamin D supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones.


Zinc can inhibit the absorption of certain antibiotics; take at least 2 hours apart to minimize interactions.


Consult appropriate references for additional specific vitamin-drug interactions.


Information for Patients: Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breast-feeding.


Pediatric Use: Not for pediatric use. 

Adverse Reactions

Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in Reaphirm Plant Source DHA.  Reported adverse events include skin ailments, gastrointestinal complaints, glucose abnormalities, and visual problems.

Dosage and Administration

Before, during and after pregnancy, one softgel capsule daily, or as directed by a physician.

How Supplied

Reaphirm Plant Source DHA is available as a dark blue, oval shaped softgel capsule imprinted "EV3010".  Available in Box of Unit-Dose pack of 30 (5 child resistant blister cards of 6 softgel capsules).

Store at room temperature, approximately 15-30C (59-86F), avoid excessive heat.

Rx Only

Manufactured for

EVERETT LABORATORIES, INC.

West Orange, NJ 07052

1-877-324-9349

Principal Display Panel

reaphirm111128carton_lcr

Reaphirm Plant Source DHA  prenatal supplement  capsule, gelatin coated

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0642-3010 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Vitamin A (Beta Carotene) Beta Carotene 1100 [iU] Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 30 mg Thiamine Mononitrate (Thiamine ) Thiamine Mononitrate 1.6 mg Riboflavin (Riboflavin) Riboflavin 1.8 mg Niacin (Niacinamide) Niacinamide 15 mg Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine 2.5  mg Cyanocobalamin (Cyanocobalamin) Cyanocobalamin .012 mg Folic Acid (Folic Acid) Folic Acid 1 mg Iodine (Iodine) Iodine 0.150 mg Magnesium (Magnesium Oxide) Magnesium Oxide 20 mg Zinc (Zinc Oxide) Zinc Oxide 25 mg Copper (Cupric Oxide) Cupric Oxide 2 mg Vitamin D (Cholecalciferol) Cholecalciferol 1000 [iU] Omega-3 Fatty Acids (Doconexent) Doconexent 200 mg Vitamin E (Alpha-Tocopherol) Alpha-Tocopherol 20 [iU] Iron (Iron) Iron 29 mg

Inactive Ingredients Ingredient Name Strength Gelatin   Sorbitol   Glycerin   Soybean Oil   Water   Yellow Wax   Anhydrous Dibasic Calcium Phosphate   Lecithin, Soybean   Titanium Dioxide   Sodium Thiosulfate   Sunflower Oil   Tocopherol   Ascorbyl palmitate   Caramel   FD&C Blue NO. 1   Corn Oil

Product Characteristics Color blue (Dark Blue) Score no score Shape OVAL (size 12 Oval Capsule) Size 10mm Flavor Imprint Code EV3010 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0642-3010-30 5 BLISTER PACK In 1 BOX contains a BLISTER PACK 1 6 CAPSULE In 1 BLISTER PACK This package is contained within the BOX (0642-3010-30)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/05/2011

Labeler - Everett Laboratories, Inc. (071170534)

Registrant - Everett Laboratories, Inc. (071170534)

Revised: 11/2011Everett Laboratories, Inc.

Spectro

Spectro may be available in the countries listed below.

Ingredient matches for Spectro

Clobetasone

Clobetasone 17α-butyrate (a derivative of Clobetasone) is reported as an ingredient of Spectro in the following countries:

• Canada

International Drug Name Search

Acediur

Acediur may be available in the countries listed below.

Ingredient matches for Acediur

Captopril

Captopril is reported as an ingredient of Acediur in the following countries:

• Italy

Enalapril

Enalapril maleate (a derivative of Enalapril) is reported as an ingredient of Acediur in the following countries:

• Spain

Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Acediur in the following countries:

• Italy


• Spain

International Drug Name Search

Logistic

Logistic may be available in the countries listed below.

Ingredient matches for Logistic

Gabapentin

Gabapentin is reported as an ingredient of Logistic in the following countries:

• Argentina

International Drug Name Search

Stiloz

Stiloz may be available in the countries listed below.

Ingredient matches for Stiloz

Cilostazol

Cilostazol is reported as an ingredient of Stiloz in the following countries:

• Vietnam

International Drug Name Search

Losap

Losap may be available in the countries listed below.

Ingredient matches for Losap

Losartan

Losartan potassium salt (a derivative of Losartan) is reported as an ingredient of Losap in the following countries:

• Bangladesh

International Drug Name Search

Ticlop

Ticlop may be available in the countries listed below.

Ingredient matches for Ticlop

Ticlopidine

Ticlopidine hydrochloride (a derivative of Ticlopidine) is reported as an ingredient of Ticlop in the following countries:

• India

International Drug Name Search

Blastocarb

Blastocarb may be available in the countries listed below.

Ingredient matches for Blastocarb

Carboplatin

Carboplatin is reported as an ingredient of Blastocarb in the following countries:

• Mexico


• Peru

International Drug Name Search