B-NEXA pyridoxine folic acid calcium and ginger tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Pyridoxine (UNII: KV2JZ1BI6Z) (Pyridoxine - UNII:KV2JZ1BI6Z)

Available from:

Upsher-Smith Laboratories, Inc.

INN (International Name):

Pyridoxine

Composition:

Pyridoxine 40 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

unapproved drug other

Summary of Product characteristics

B-NEXA- PYRIDOXINE, FOLIC ACID, CALCIUM, AND GINGER TABLET
UPSHER-SMITH LABORATORIES, INC.
_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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B-NEXA TABLETS
RX ONLY
DESCRIPTION
B-Nexa
Tablets are a prescription prenatal vitamin that provide B-vitamin
nutrition and are formulated
with vitamin B and ginger to help calm nausea and vomiting of
pregnancy (NVP). B-Nexa
Tablets
contain 100 mg ginger root powder extract that, when standardized to
gingerols, is equivalent to 500 mg
ginger root powder. Each caplet shaped tablet is engraved "US" on one
side and "214" on the other with
a pink film coat.
EACH PINK TABLET CONTAINS:
Vitamin B (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, talc,
corn starch, croscarmellose sodium,
stearic acid, hypromellose, hydroxypropyl cellulose, magnesium
stearate, silicon dioxide, titanium
dioxide, iron oxide red, iron oxide yellow, iron oxide black.
INDICATIONS
B-Nexa
Tablets are indicated to provide B-vitamin supplementation, with
ginger to help calm
pregnancy related nausea and vomiting (morning sickness), and may be
used in conjunction with a
physician prescribed prenatal regimen.
CONTRAINDICATIONS
This product is contraindicated in patients with a known
hypersensitivity to any of the ingredients.
PRECAUTIONS
Folic acid alone is improper therapy in the treatment of pernicious
anemia and other megaloblastic
anemias where vitamin B
is deficient. Folic acid in doses above 1 mg daily may obscure
pernicious
anemia in that hematologic remission can occur while neurological
manifestations progress.
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.
ADVERS