ZELDANA- folate, cyanocobalamin, thiamine hydrochloride, riboflavin, pyridoxine hydrochloride, niacinamide, ascorbic acid, pantothenic acid capsule

Zeldana by

Drug Labeling and Warnings

Zeldana by is a Other medication manufactured, distributed, or labeled by Misemer Pharmaceutical, Viva Pharmaceutical Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Zeldana Label

HEALTH CLAIM

Zeldana is intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impaired chronic medical needs, has limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other specific medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of a normal diet alone.

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under physician's supervision. There are no implied or explicit claims on therapeutic equivilance

Manufactured for:

Misemer Pharmaceutical, Inc.

Ripley, MS 38663

Item 0708

Rev. 0821-1

DOSAGE & ADMINISTRATION

Usual adult dosage is one to two capsule daily or as directed by a licensed medical practitioner. Zeldana capsules are supplied as purple capsules printed with "354", dispensed in HDPE plastic bottles of 30ct.

PRECAUTIONS

Folic Acid, when administered as a single agent in doses above .1mg daily, may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. The .5 mg of cyanocobalamin contained in Zeldana has been shown to provide an adequate amount of cyanocobalamin to address this precaution. A safe upper limit of 100 mg per day has been established for the unsupervised medical use of pyridoxine. Consider all sources of pyridoxine supplementation when prescribing Zeldana.

If pregnant or planning to become pregnant or are currently breastfeeding, please contact your physician or health-care provider before using or continuing use.

ADVERSE REACTIONS

Allergic sensitization has been reported following both oral and parenteral administration of folic acid. Paresthesia and somnolence have been reported with pyridoxine HCl. Mild transient diarrhea, polycthemia vera, peripheral vascular thrombosis, itching transitory exanthema and feeling of swelling of entire body has been associated with cyanocobalamin.

DRUG INTERACTIONS

Pyridoxine supplements should not be given to patients receiving the drug levodopa, beause the action of levodopa is antagonized by pyidoxine. However, pyridoxine may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. Concurrent use of phenytoin and folacin (folic acid) may result in decreased phenytoin effectiveness.

PATIENT INFORMATION

Zeldana capsules are for use only under the direction and supervision of a licensed physician or health-care provider.

PREGNANCY and NURSING MOTHERS

Zeldana is not intended for use as a prenatal/postnatal multivitamin for lactating in non-lactating mothers. This product contains B Vitamins in active forms. Talk with your medical pratitioner before using if pregnant or lactating.

STATEMENT OF IDENTITY

Zeldana is an orally administered prescription supplement indicated for the distinct nutritional requirements of patients in need of dietary supplementation as determined by a licensed medical practitioner. Zeldana should be administered under the supervision of a licensed medical practitioner.

SAFE HANDLING WARNING

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.

Store at controlled room temperature 15*-30*C (59*F-86*F). Keep in cool dry place. Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088. KEEP THIS OUT OF THE REACH OF CHILDREN.

Dispense by Prescription

WARNINGS

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Zeldana should only be used under the diretion and supervision of a licensed medical practioner. Use with caution in patients that may have a medical condition, are pregnant, lactating, trying to conceive, under the age of 18, or taking medications.

INGREDIENTS AND APPEARANCE

ZELDANA 
folate, cyanocobalamin, thiamine hydrochloride, riboflavin, pyridoxine hydrochloride, niacinamide, ascorbic acid, pantothenic acid capsule

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:0276-0708
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	.5 mg
THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE HYDROCHLORIDE	5 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	5 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	25 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	35.7 mg
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	65 mg
PANTOTHENIC ACID (UNII: 19F5HK2737) (PANTOTHENIC ACID - UNII:19F5HK2737)	PANTOTHENIC ACID	20 mg

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
GELATIN TYPE B BOVINE (150 BLOOM) (UNII: F5AJW0ONK4)
SOYBEAN OIL (UNII: 241ATL177A)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:0276-0708-30	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
dietary supplement		12/01/2021

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
imprint
size (solid drugs)	14 mm
shape
scoring	1

Labeler - Misemer Pharmaceutical (784121365)

Registrant - Misemer Pharmaceutical (784121365)

Establishment
Name	Address	ID/FEI	Business Operations
Viva Pharmaceutical Inc		253288898