The following Structured Product Label (SPL) was submitted to the FDA by Prugen, Inc. Pharmaceuticals for the product Zingiber (NDC 42546-300). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding warnings and precautions, description, dosage & administration, how supplied, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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 (Label)
* Please review the disclaimer below.
