Renate DHA

Generic Name: prenatal multivitamin and minerals
Dosage Form: tablet

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Renate DHA Prenatal Multivitamin and Minerals

Renate DHA Description

Renate DHA Extra 430 mg is a high-potency, multivitamin,
multi-mineral nutritional supplement with DHA (Omega-3 Fatty Acid).

Other Ingredients (Renate DHA Extra
430 mg caplet): Mono and Diglycerides,
Croscarmellose Sodium, Maltodextrin, Microcrystalline
Cellulose, Crospovidone, Stearic Acid, Hydroxypropyl
Methylcellulose, Titanium Dioxide, Magnesium Stearate,
Silicon Dioxide, Acacia, Sucrose, Starch, Gelatin, Dicalcium
Phosphate, Triacetin, Ascorbyl Palmitate, dl-Alpha
Tocopherol, Sodium Ascorbate, Carmine Powder
CFR73.100/E120, Caramel Color CFR73.85/E150,
Polysorbate. May contain Polyethylene Glycol.
Contains Soy.

Other Ingredients (Renate DHA
Extra 430 mg Enteric-Coated
softgel): Gelatin, Water, Glycerin, Polysorbate 80,
Ethylcellulose, Sodium Alginate, Polyethylene Glycol,
Oleic Acid, Fractionated Coconut Oil, Purified Stearic
Acid, Ammonium Hydroxide.
Also contains Eicosapentaenoic Acid (EPA) and other
omega-3 fatty acids (from tuna oil).
Contains Soy and Fish Oil (from tuna oil).

Contains NO artificial flavors or preservatives, yeast, wheat, gluten, nuts or milk-based
by-products.

WARNING: Accidental overdose of iron-containing products is a leading cause of
fatal poisoning in children under 6. Keep this and all drugs out of reach of children. In
case of accidental overdose, call a doctor or poison control center immediately.
Renate DHA Extra 430 mg supplies important prenatal vitamins, minerals and nutrients
to supplement the nutritional needs of women, before, during and after pregnancy.
Deficiencies of these nutrients are common during pregnancy and lactation, and should
be prescribed by a physician prior to conception.

Renate DHA Extra 430 mg caplet is manufactured in a drug-certified cGMP (current
good manufacturing practices) facility and meets or exceeds USP standards for potency,
purity and dissolution. Renate DHA Extra 430 mg Enteric-Coated softgel complies with
the most stringent worldwide standards for fish oil and is manufactured in a NSF
Certified cGMP Facility.

Indications and Usage for Renate DHA

Renate DHA Extra 430 mg is a prescription regimen
of prenatal multivitamin, multi-mineral and omega-3 fatty acid supplements indicated
for use in improving the nutritional status of women throughout pregnancy and in the
post-natal period for both lactating and non-lactating mothers. Renate DHA Extra
430 mg is also useful in improving the nutritional status prior to conception.

Renate DHA Dosage and Administration

Before, during and after pregnancy, adult
women (over 12 years of age), take one (1) caplet and one (1) softgel by mouth daily,
between meals or as prescribed by a physician. Caplet and softgel may be taken
separately. Do not exceed the recommended dosage. Do not administer to children
under 12 years of age or persons age 65 or older. Do not exceed one gram (1,000 mg)
of DHA per day.

Contraindications

Renate DHA Extra 430 mg is contraindicated in patients
with a known hypersensitivity to any of the ingredients, including fish oil and soy. Iron is
contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic
anemias. This product is contraindicated for persons with pernicious anemia, as folic
acid may obscure its signs and symptoms.
WARNING: Folic acid alone is improper therapy in the treatment of pernicious anemia
in that hematological remission can occur while neurological manifestations remain
progressive.

Warning

Ingestion of omega-3 fatty acids (including alpha-linolenic acid [ALA],
eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA] from fish oils) of more
than 3 grams per day may present antithrombotic effects, including increased bleeding
time. Omega-3 fatty acids including DHA and EPA should be avoided in patients with
inherited or acquired bleeding diatheses. Patients taking anticoagulant drug products
should consult with their physician prior to ingesting omega-3 fatty acids.

Precautions

Folic acid in dosages above 400 mcg daily may obscure
megaloblastic (pernicious) anemia in that hematological remission can occur while
neurological manifestations (Addisonian anemia) remain progressive.

Adverse Reactions

Iron: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) can occur
but are usually mild and can subside with continuation of therapy. Although the
absorption of iron is best when taken between meals, Renate DHA Extra 430 mg, when
taken after meals, may control occasional G.I. disturbances. Renate DHA Extra 430 mg
is best absorbed when taken at bedtime.

Folic Acid: Allergic sensitizations have been reported following both oral and
parenteral administration of folic acid.

Call your doctor for medical advice about side effects. You may
report suspected side effects to the FDA at: 1-800-FDA-1088.

USE IN SPECIFIC POPULATIONS

Renate DHA Extra 430 mg is not advocated
for pediatric or geriatric use.

OVERDOSE

Iron: Signs and Symptoms: Iron is toxic. Acute overdosage of iron may
cause nausea and vomiting. In severe cases, iron overdose can cause cardiovascular
collapse and death. Other symptoms include pallor and cyanosis, melena, shock,
drowsiness and coma. The estimated overdose of orally ingested iron is 300mg/kg body
weight. When overdoses are ingested by children, severe reactions, including fatalities
have resulted. Renate DHA Extra 430 mg should be stored beyond the reach of children
to prevent against accidental iron poisoning. Keep this and all other drugs out of reach
of children. Treatment: For specific therapy, exchange transfusion and chelating agents
should be used. For general management, perform gastric lavage with sodium
bicarbonate solution or milk. Administer intravenous fluids and electrolytes and use
oxygen.

How is Renate DHA Supplied

Renate DHA Extra 430 mg is a 30-day regimen supplied as one
bottle containing 30 dark red Renate DHA Extra 430 mg Prenatal capsule-shaped
caplets imprinted “RE 340” and one bottle containing 30 light yellow DHA,
Enteric-Coated softgels. NDC: 68032-373-60. Dispense in tight, light-resistant
containers as defined in the USP/NF with child resistant closures. Store at controlled
room temperature 15°-30°C (59°-86°F). Keep in a cool, dry place.

CAUTION: Rx Only

RESERVED FOR PROFESSIONAL RECOMMENDATION: Made in the
USA exclusively for River’s Edge Pharmaceuticals, LLC, Suwanee, GA, 30024. All rights
reserved. Copyright © by River’s Edge Pharmaceuticals.

PACKAGING

Sample Packaging:

Slideshow: OTC Medication Use In Pregnancy: Wise or Worrisome?

RENATE 
Renate DHA prenatal multivitamin and minerals with dha tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68032-373
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETA CAROTENE (BETA CAROTENE) BETA CAROTENE 3000 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
ALPHA-TOCOPHEROL (ALPHA-TOCOPHEROL) ALPHA-TOCOPHEROL 3 mg
THIAMINE MONONITRATE (THIAMINE) THIAMINE MONONITRATE 1.8 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 4 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 25 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
CALCIUM CARBONATE (CALCIUM) CALCIUM CARBONATE 200 mg
IRON (IRON) IRON 29 mg
MAGNESIUM OXIDE (MAGNESIUM) MAGNESIUM OXIDE 25 mg
ZINC OXIDE (ZINC) ZINC OXIDE 25 mg
CUPRIC OXIDE (CUPRIC CATION) CUPRIC OXIDE 2 mg
OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) OMEGA-3-ACID ETHYL ESTERS 430 mg
DOCONEXENT (DOCONEXENT) DOCONEXENT 295 mg
Product Characteristics
Color red Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code RE;340
Contains         
Packaging
# Item Code Package Description
1 NDC:68032-373-60 60 TABLET (TABLET) in 1 KIT
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/02/2009 12/31/2010
Labeler - River's Edge Pharmaceuticals, LLC (133879135)
Revised: 12/2009
 
River's Edge Pharmaceuticals, LLC
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