Label: ZINGIBER- pyridoxine, folic acid, calcium, and ginger tablet tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 42546-300-60 - Packager: PruGen, Inc. Pharmaceuticals
- Category: HUMAN PRESCRIPTION DRUG LABEL
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.
Drug Label Information
Updated February 22, 2013
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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.
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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.
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INGREDIENTS AND APPEARANCE
ZINGIBER
pyridoxine, folic acid, calcium, and ginger tablet tabletProduct 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)
