COMPLETENATE CHEWABLE- .beta.-carotene, ascorbic acid, sodium ascorbate, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, and ferrous fumarate tablet

CompleteNate Chewable by

Drug Labeling and Warnings

CompleteNate Chewable by is a Other medication manufactured, distributed, or labeled by Trigen Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

WARNINGS

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

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.

DIRECTIONS FOR USE

Take one tablet by mouth daily or as directed by a physician.

HOW SUPPLIED

CompleteNate Chewable is supplied in bottles of 90 tablets.

PRODUCT CODE 13811-014-90

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.

HEALTH CLAIM

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 1-888-9-TRIGEN (1-888-987-4436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

                                                                                                                                                                                            Rev. 10/2018
Customer Service: 1-888-987-4436

Manufactured for:
Trigen Laboratories, LLC                                                                                                                                           
Bridgewater, NJ 08807
www.trigenlab.com

PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label

13811-014-90

90 Tablets

CompleteNate
Chewable

Chewable Prenatal Multivitamin Tablet with Iron

TRIGEN
LABORATORIES

INGREDIENTS AND APPEARANCE

COMPLETENATE CHEWABLE 
.beta.-carotene, ascorbic acid, sodium ascorbate, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, and ferrous fumarate tablet

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:13811-014
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
.beta.-carotene (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J)	.beta.-carotene	1000 [iU]
ascorbic acid (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ascorbic acid	48 mg
sodium ascorbate (UNII: S033EH8359) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	72 mg
cholecalciferol (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	cholecalciferol	400 [iU]
.alpha.-tocopherol acetate, dl- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01)	.ALPHA.-TOCOPHEROL, DL-	11 [iU]
thiamine mononitrate (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	2 mg
riboflavin (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	riboflavin	3 mg
niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	niacinamide	20 mg
pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	pyridoxine Hydrochloride	10 mg
folic acid (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	folic acid	1 mg
cyanocobalamin (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	cyanocobalamin	12 ug
ferrous fumarate (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	29 mg

Inactive Ingredients
Ingredient Name	Strength
sorbitol (UNII: 506T60A25R)
sucrose (UNII: C151H8M554)
magnesium stearate (UNII: 70097M6I30)
stearic acid (UNII: 4ELV7Z65AP)
gelatin (UNII: 2G86QN327L)
stevia rebaudiuna leaf (UNII: 6TC6NN0876)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ORANGE OIL (UNII: AKN3KSD11B)
ORANGE (UNII: 5EVU04N5QU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:13811-014-90	90 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		07/01/2010

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
flavor
imprint
scoring	1
shape
size (solid drugs)	12 mm

Labeler - Trigen Laboratories, LLC (830479668)