Healthcare Professionals
Animi-3®
Each Capsule contains:
- Folic Acid 1 mg
- Vitamin B6 12.5 mg
- Vitamin B12 500 mcg
- Omega-3 Acids 500 mg
- Docosahexaenoic Acid (DHA) 350
mg
- Eicosapentaenoic Acid (EPA) 35
mg
- Phytosterols 200mg
Patent Pending
Rx Only
Description
Animi-3® Capsules are intended for oral administration.
Each Capsule Contains: 1 mg Folic Acid USP, 12.5 mg Vitamin B-6 (Pyridoxine
Hydrochloride, USP), 500 mcg Vitamin B-12 (Cyanocobalamin, USP), 200 mg
Phytosterols and Pharmaceutical Grade Omega-3 Fish Oil providing 500 mg Omega-3
Acids; including 350 mg Docosahexaenoic Acid (DHA) and 35 mg Eicosapentaenoic
Acid (EPA).
Also Contains: Bleached Lecithin NF, Ascorbic Acid USP, Mixed Tocopherols
NF, Ascorbyl Palmitate NF and a soft shell capsule (which contains; Gelatin USP,
Glycerin NF, Titanium Dioxide USP, FD&C Red 40 and USP Purified Water).
Indication
Animi-3® Capsules are indicated for improving nutritional status in
conditions requiring Essential Fatty Acid, Vitamin B12, B6 and Folic Acid
supplementation as well as for patients where cholesterol levels are a concern.
Contraindications
This product is contraindicated in patients with a known
hypersensitivity to any of the ingredients.
Precautions
Folic Acid in doses above 0.1 mg daily may obscure pernicious anemia in that
hematological remission can occur while neurological manifestations remain
progressive.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Pregnancy
and Lactation
The safety of
phytosterols has not been studied in pregnant or breastfeeding women. There is
no evidence that dietary intakes of naturally occurring phytosterols, such as
those consumed by vegetarian women, adversely affects pregnancy or lactation.
Adverse Reactions
Allergic sensitization has been reported following oral, enteral and parenteral
administration of folic acid.
Dosage and Administration
Adults - One to Four capsules daily or as directed by a physician.
How Supplied
Animi-3® supplied as red opaque oblong Capsules. Each Capsule is
imprinted with “Animi-3” in black opacode. Animi-3® Capsules are available in
bottles of 60 capsules (NDC 66213-0541-60).
Keep out of reach of children.
Dispense in a well-closed, tight light-resistant container as defined in the
USP using a child-resistant closure.
Storage Conditions
Store at 20-25°C (68-77°F).
See USP Controlled Room Temperature. Protect from light and moisture.
PBM Pharmaceuticals, Inc.
Gordonsville, VA 22942
Rev. 0705
© 2005 All Rights Reserved.
Healthcare Professionals:
Call (800) 485-9828
for Animi-3 samples.
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