RxNorm Names

Not yet provided

SHARK CARTILAGE liquid
[BioActive Nutritional, Inc.]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d9176329-7abe-4af2-991a-ccf3e32482a4

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

Shark Cartilage 12X

INDICATIONS

For temporary relief of painful lower back with burning, looseness of ligaments and general soreness, aching tendons, ligaments, and bones.

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

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

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 painful lower back with burning, looseness of ligaments and general soreness, aching tendons, ligaments, and bones.

QUESTIONS

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

BioActive homeopathic

SHARK CARTILAGE 12X

2 FL OZ (60 ml)

Shark Cartilage 12X

SHARK CARTILAGE
shark cartilage liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43857-0076
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SHARK CARTILAGE (SHARK CARTILAGE)	SHARK CARTILAGE	12 [hp_X] in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
ALCOHOL

Packaging
#	Item Code	Package Description
1	NDC:43857-0076-1	60 mL in 1 BOTTLE, DROPPER

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(43857-0076)

Revised: 10/2012

Document Id: 914f1d20-e265-46d0-b006-c5aeb4d362a4

Set id: d9176329-7abe-4af2-991a-ccf3e32482a4

Version: 1

Effective Time: 20121008