ELITE OB PRENATAL MULTIVITAMIN- beta carotene, thiamine mononitrate, riboflavin, pyridoxine hcl, cyanocobalamin, folic acid, cholecalciferol, ascorbic acid, d-alpha succinate, niacinamide, pantothenic acid,gluconate, magnesium oxide, zinc oxide and ferronyl, micronised tablet 
Trigen Laboratories, LLC

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Elite OBTM

SUPPLEMENT FACTS

Elite OB Supplement Facts Table

Other Ingredients: Microcrystalline Cellulose, Di Cal Phosphate, Croscarmellose Sodium, Pink Color Coating (Hydroxypropylmethyl Cellulose, Polyvinyl Alcohol, Titanium Dioxide, Polyethylene Glycol, Talc, FD&C Red #40 Lake), Fumed Silica, Stearic Acid, Magnesium Stearate, Povidone K30, Acacia.

GLUTEN, SUGAR, AND LACTOSE FREE

Elite OB™ is a prescription multivitamin/multimineral indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and non-lactating mothers.

CONTRAINDICATIONS

Elite OB™ should not be used by patients with a known hypersensitivity to any of the listed ingredients.

WARNINGS

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 poison control center immediately.

PRECAUTIONS

Folic acid alone is an 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. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.

DRUG INTERACTIONS

Elite OB™ caplets are 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

Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients.

DESCRIPTION

Elite OB™ is a pink capsule shaped caplet imprinted with "VP 010".

DIRECTIONS FOR USE

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

HOW SUPPLIED

Elite OBTM is available as a pink capsule shaped caplet. Available in unit-dose pack of 100 (10x10)

STORAGE

Store at controlled room temperature 15º-30ºC (59º-86ºF). [See USP]. Protect from light and moisture and avoid excessive heat.

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-EOB-00002-1   Rev. 12/2021

Manufactured for:

Trigen Laboratories, LLC

Alpharetta, GA 30005

www.trigenlab.com

Trigen Logo

PRINCIPAL DISPLAY PANEL - 100 tablet label

13811-027-10

Elite OBTM

Prenatal
Multivitamin

TRIGEN
LABORATORIES

Elite OB Carton Rev. 12/2021
ELITE OB  PRENATAL MULTIVITAMIN
beta carotene, thiamine mononitrate, riboflavin, pyridoxine hcl, cyanocobalamin, folic acid, cholecalciferol, ascorbic acid, d-alpha succinate, niacinamide, pantothenic acid,gluconate, magnesium oxide, zinc oxide and ferronyl, micronised tablet
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:13811-027
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A2100 [iU]
THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE2 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3.40 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE10 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN15 ug
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1.25 mg
VITAMIN D (UNII: 9VU1KI44GP) (CHOLECALCIFEROL - UNII:1C6V77QF41) VITAMIN D315 [iU]
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
.ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL SUCCINATE, D-20 [iU]
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE10 mg
PANTOTHENIC ACID (UNII: 19F5HK2737) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID5 mg
COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER1 mg
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE15 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 mg
Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron50 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE K30 (UNII: U725QWY32X)  
ACACIA (UNII: 5C5403N26O)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
TALC (UNII: 7SEV7J4R1U)  
MINERAL OIL (UNII: T5L8T28FGP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:13811-027-1010 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT07/13/2013
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
imprint
scoring1
shape
size (solid drugs)19 mm
Labeler - Trigen Laboratories, LLC (830479668)

Revised: 12/2021
Document Id: 18553b21-925a-4b37-9012-37b00af37b82
Set id: 6aead698-0370-4d05-9e22-61b9ea5f6b61
Version: 4
Effective Time: 20211230
 
Trigen Laboratories, LLC