Zingiber

ZINGIBER- pyridoxine, folic acid, calcium and ginger 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.

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

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRIDOXINE (PYRIDOXINE) PYRIDOXINE 40 mg FOLIC ACID (FOLIC ACID) FOLIC ACID 1.2 mg CALCIUM (CALCIUM) CALCIUM 124.1 mg GINGER (GINGER) GINGER 100 mg

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE MALTODEXTRIN STEARIC ACID CROSCARMELLOSE SODIUM STARCH, CORN MAGNESIUM STEARATE SILICON DIOXIDE TALC HYPROMELLOSES HYDROXYPROPYL CELLULOSE POLYDEXTROSE TITANIUM DIOXIDE MEDIUM-CHAIN TRIGLYCERIDES FD&C RED NO. 40

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

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:42546-300-60 60 TABLET in 1 BOTTLE None

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	Operations
NuLab, Inc		102098324	manufacture (42546-300)

Revised: 02/2013 PruGen, Inc. Pharmaceuticals