ZINGIBER- pyridoxine, folic acid, calcium, and ginger tablet tablet 
PruGen, Inc. Pharmaceuticals

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Zingiber

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.

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.

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

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

NDC 42546-300-60

Zingiber Tablets

Rx prenatal vitamin with B vitamins and ginger

Rx Only

60 tablets

label

ZINGIBER 
pyridoxine, folic acid, calcium, and ginger tablet tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42546-300
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE40 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1.2 mg
CALCIUM (UNII: SY7Q814VUP) (CALCIUM - UNII:SY7Q814VUP) CALCIUM124.1 mg
GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER100 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorpinkScoreno score
ShapeOVALSize24mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42546-300-6060 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/01/2013
Labeler - PruGen, Inc. Pharmaceuticals (929922750)
Establishment
NameAddressID/FEIBusiness Operations
NuLab, Inc102098324manufacture(42546-300)

Revised: 2/2013
Document Id: 3a11164d-6eb1-4a01-8722-0086f94a85b3
Set id: 209da0f4-93d4-4690-9f07-7829334ce012
Version: 2
Effective Time: 20130222
 
PruGen, Inc. Pharmaceuticals