ZINGIBER- pyridoxine, folic acid, calcium, and ginger tablet tablet

Zingiber by

Drug Labeling and Warnings

Zingiber by is a Prescription medication manufactured, distributed, or labeled by PruGen, Inc. Pharmaceuticals, NuLab, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS AND PRECAUTIONS

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid especially in doses above 1 mg daily may obscure pernicious anemia in that hematologic remission may occur while neurological manifestations remain progressive.

Concomitant use of ginger in patients with bleeding disorders, or who are on anti-coagulant or anti-platelet therapy, may increase the risk of bleeding.

DESCRIPTION

Each pink tablet contains:

Vitamin B6 (pyridoxine hydrochloride, USP) 40 mg

Folic Acid, USP 1.2 mg

Calcium (as dicalcium phosphate and tricalcium phosphate) 124.1 mg

Ginger (zingiber officinale) root powder extract 100 mg

Other ingredients: microcrystalline cellulose, maltodextrin, stearic acid, croscarmellose sodium, corn starch, magnesium stearate, silicon dioxide, talc, hypromellose, hydroxypropyl cellulose, polydextrose, titanium dioxide, medium chain triglycerides, FD&C Red #40.

DOSAGE & ADMINISTRATION

One or two tablets daily, in divided doses, or as directed by a physician.

HOW SUPPLIED

Store between 15-30°C (59-86°F). Protect from light and moisture.

Keep out of the reach of children.

DO NOT CHEW.

Manufactured for:

PruGen, Inc. Pharmaceuticals

8714 E Vista Bonita Dr

Scottsdale, AZ 85255

PRINCIPAL DISPLAY PANEL

NDC: 42546-300-60

Zingiber Tablets

Rx prenatal vitamin with B vitamins and ginger

Rx Only

60 tablets

INGREDIENTS AND APPEARANCE

ZINGIBER 
pyridoxine, folic acid, calcium, and ginger tablet tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 42546-300
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	40 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1.2 mg
CALCIUM (UNII: SY7Q814VUP) (CALCIUM - UNII:SY7Q814VUP)	CALCIUM	124.1 mg
GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ)	GINGER	100 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
STEARIC ACID (UNII: 4ELV7Z65AP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
STARCH, CORN (UNII: O8232NY3SJ)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
HYPROMELLOSES (UNII: 3NXW29V3WO)
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)
POLYDEXTROSE (UNII: VH2XOU12IE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	pink	Score	no score
Shape	OVAL	Size	24mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42546-300-60	60 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/01/2013

Labeler - PruGen, Inc. Pharmaceuticals (929922750)

Establishment
Name	Address	ID/FEI	Business Operations
NuLab, Inc		102098324	manufacture(42546-300)