![B-SERENE RX (PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, FOLIC ACID, AND GINGER) PATCH [SPRING HILL THERAPEUTICS LLC]](https://medic.hrt.org//dailymed/images/93799d12-78fe-4c08-87fe-61acb145d9b0/b-serene-01.jpg)
| NDC | 69833-030-30 |
| Set ID | 93799d12-78fe-4c08-87fe-61acb145d9b0 |
| Category | DIETARY SUPPLEMENT |
| Packager | Spring Hill Therapeutics LLC |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
- STATEMENT OF IDENTITY
Close
Supplement Facts Active Ingredients
Serving Size: 1 patchAmount per serving %DV Daily Value for adults and children four or more years of age - *
- Daily Value (DV) not established
Vitamin B6 (Pyridoxine Hydrochloride) 75 mg 3000% Vitamin B12 (Cyanocobalamin) 12 mcg 150% Folic Acid 1.2 mg 150% Ginger 500 mg * - Uses
B-Serene Rx is indicated to provide B-Vitamin supplementation, with ginger to help calm preganancy related nausea and vomiting (morning sickness), and may be used in conjunction with a physician prescribed prenatal regimen.
Close - Warnings
For external use only • Use only as directed • Avoid contact with eyes and mucous membranes • Do not use with heating devices or pads • Do not bandage tightly • If contact does occur with eyes rinse with cold water and call a doctor • Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. While prescribing this nutritional supplement for pregnant women, nursing mothers or for women prior to conception, their medical condition and any drugs, herbs and/or supplements consumption should be considered. • Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately. Concomitant use of ginger in pateints with heavy bleeding disorders, or who are on anti-coagulant or anti-platelet therapy, may increase the risk of bleeding.
Close - Inactive Ingredients
- Do not use
On wounds or damaged skin. Children under 12 years old, consult a doctor. If you are allergic to any ingredients in this product. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.
Keep out of the reach of children.
Close - Directions
- Other Information
Store at 25°C (77°F) excursions permitted to 15°-30°C (59°-86° F)
See USP Controlled Room Temperature • Protect from freezing.
Close - HEALTH CLAIM
These statements have not been approved by the FDA, This product is not intended to diagnose, treat, cure or prevent any disease.
SPRING HILL
THERAPEUTICS8270 Woodland Center Blvd. • Tampa, FL 33614
Close
FOR QUESTIONS CALL 813-388-8735 - PRINCIPAL DISPLAY PANEL - 30 Patch Bag Label
B-SereneRx
- Anti-Nausea Patch
- Dietary Supplement
- Rx prenatal vitamin with B Vitamins and Ginger
- Formulated to ease symptoms commonly associated
with pregnancy, including nausea and vomiting.
30 Patches
NDC # 69833-030-30
Rx OnlyClose
- INGREDIENTS AND APPEARANCE
B-SERENE RX
pyridoxine hydrochloride, cyanocobalamin, folic acid, and ginger patchProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:69833-030 Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride 75 mg Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin 12 ug Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid 1200 ug Ginger (UNII: C5529G5JPQ) (Ginger - UNII:C5529G5JPQ) Ginger 500 mg Inactive Ingredients Ingredient Name Strength 2-Ethylhexyl Acrylate (UNII: HR49R9S6XG) Methacrylic Acid (UNII: 1CS02G8656) Bentonite (UNII: A3N5ZCN45C) Sodium Stearate (UNII: QU7E2XA9TG) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:69833-030-30 30 in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 01/05/2015 CloseLabeler - Spring Hill Therapeutics LLC (079813250)