B-SERENE RX- pyridoxine hydrochloride, cyanocobalamin, folic acid, and ginger patch 
Spring Hill Therapeutics LLC

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B-SereneRx

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 mg3000%
Vitamin B12 (Cyanocobalamin)12 mcg150%
Folic Acid1.2 mg150%
Ginger500 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.

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

30 Patches
NDC # 69833-030-30
Rx Only

PRINCIPAL DISPLAY PANEL - 30 Patch Bag Label
B-SERENE RX 
pyridoxine hydrochloride, cyanocobalamin, folic acid, and ginger patch
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:69833-030
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride75 mg
Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin12 ug
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid1200 ug
Ginger (UNII: C5529G5JPQ) (Ginger - UNII:C5529G5JPQ) Ginger500 mg
Inactive Ingredients
Ingredient NameStrength
2-Ethylhexyl Acrylate (UNII: HR49R9S6XG)  
Methacrylic Acid (UNII: 1CS02G8656)  
Bentonite (UNII: A3N5ZCN45C)  
Sodium Stearate (UNII: QU7E2XA9TG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:69833-030-3030 in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT01/05/2015
Labeler - Spring Hill Therapeutics LLC (079813250)

Revised: 1/2016
Document Id: b30ddeb3-da38-44c7-a7fb-d1ee25fc660b
Set id: 93799d12-78fe-4c08-87fe-61acb145d9b0
Version: 1
Effective Time: 20160114
 
Spring Hill Therapeutics LLC