B-SERENE RX- pyridoxine hydrochloride, cyanocobalamin, folic acid, and ginger patch

B-Serene Rx by

Drug Labeling and Warnings

B-Serene Rx by is a Other medication manufactured, distributed, or labeled by Spring Hill Therapeutics LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

Supplement Facts
Active Ingredients Serving Size: 1 patch	Amount 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.

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.

Inactive Ingredients

Methacrylic acid, ethylhexylacrylate, bentonite, sodium stearate.

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.

Directions

Use one patch as directed or every 6-12 hours.

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.

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
THERAPEUTICS

8270 Woodland Center Blvd. Tampa, FL 33614
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 Only

INGREDIENTS AND APPEARANCE

B-SERENE RX 
pyridoxine hydrochloride, cyanocobalamin, folic acid, and ginger patch

Product 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

Labeler - Spring Hill Therapeutics LLC (079813250)