SUPPLEMENT FACTS
Other Ingredients: Sorbitol, Sucrose, Natural Orange Flavor, Orange Juice Powder, Magnesium Stearate, Stearic Acid, Gelatin, Stevia, Fumed Silica.
CompleteNate Chewable tablets are formulated to provide vitamin and mineral supplementation throughout pregnancy and during postnatal period, for both the lactating and non-lactating mother. It is also useful for improving nutritional status prior to conception.
CONTRAINDICATIONS
CompleteNate Chewable should not be used by patients with a known hypersensitivity to any of the listed ingredients. All iron compounds are contraindicated in patients with hemochromatosis, hemosiderosis, or hemolytic anemias.
| 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
Folic acid alone is 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.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: Safety and effectiveness in elderly patients have not been established.
DRUG INTERACTIONS
CompleteNate Chewable Tablets is 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).
ADVERSE REACTIONS
Folic Acid: Allergic sensitizations have been reported following both oral and parenteral administration of folic acid.
Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and may subside with continuation of therapy and physician encouragement. Although the absorption of iron is best when taken between meals, occasional G.I. disturbances may be controlled by giving CompleteNate Chewable shortly after meals.
The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.
OVERDOSAGE
Iron is toxic. When overdoses are ingested by children, severe reactions, including fatalities, have resulted. CompleteNate Chewable should be stored beyond the reach of children to protect against accidental iron poisoning.
DESCRIPTION
CompleteNate Chewable is an orange-flavored, round, speckled light brown tablet debossed with “TL014” on one side.
STORAGE
Store at 20°-25°C (68°-77°F), relative humidity no higher than 65%; excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Protect from moisture and excessive heat. Note that contact with moisture may produce surface discoloration of the tablet. Dispense in a tight, light-resistant container with a child resistant closure as defined by the USP.
KEEP OUT OF REACH OF CHILDREN.
For use on the order of a healthcare practitioner.
Call your doctor about side effects. To report side effects, call Trigen Laboratories, LLC at 1-770-509-4500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
PLR-CNC-00002-1 Rev. 12/2021
Manufactured for:
Trigen Laboratories, LLC
Alpharetta, GA 30005
www.trigenlab.com
