RxNorm Names

Review RxNorm Normal Forms

SPLEEN liquid
[BioActive Nutritional, Inc.]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=cb56c58f-2f2f-4803-8659-9a34681a9b8e

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		unapproved homeopathic

NOTE:THIS HOMEOPATHIC PRODUCT HAS NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION FOR SAFETY OR EFFICACY. FDA IS NOT AWARE OF SCIENTIFIC EVIDENCE TO SUPPORT HOMEOPATHY AS EFFECTIVE.

Drug Label Sections

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

ACTIVE INGREDIENTS

Spleen (Bovinum) 6X

INDICATIONS

For temporary relief of symptoms due to spleen dysregulation.

WARNINGS

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if tamper evident seal is broken or missing. Store in cool, dry place.

DIRECTIONS

Three sprays per day. Hold in mouth for two minutes.

INACTIVE INGREDIENTS

Demineralized water, 25% Ethanol.

KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS AND USAGE

For temporary relief of symptoms due to spleen dysregulation.

QUESTIONS

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

BioActive Homeopathic

SPLEEN 6X

1 FL OZ (30 ml)

Spleen 6X

SPLEEN
spleen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43857-0119
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BOS TAURUS SPLEEN (BOS TAURUS SPLEEN)	BOS TAURUS SPLEEN	6 [hp_X] in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
ALCOHOL

Packaging
#	Item Code	Package Description
1	NDC:43857-0119-1	30 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/08/2012

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43857-0119)

Revised: 10/2012

Document Id: 6e27078b-f276-403b-ae69-80ac0d76c27f

Set id: cb56c58f-2f2f-4803-8659-9a34681a9b8e

Version: 1

Effective Time: 20121008