Apis Aconitum by Uriel Pharmacy Inc. APIS ACONITUM liquid

Apis Aconitum by

Drug Labeling and Warnings

Apis Aconitum by is a Homeopathic medication manufactured, distributed, or labeled by Uriel Pharmacy Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

Directions: FOR ORAL USE ONLY.

DOSAGE & ADMINISTRATION

Take 3-4 times daily. Ages 12 and older: 10 drops. Ages 2-11: 5 drops. Under age 2: Consult a doctor.

ACTIVE INGREDIENT

Active Ingredients: Apis (Honeybee) 3X, Atropa belladonna (Nightshade) 3X, Aconitum (Monkshood) 12X

INACTIVE INGREDIENT

Inactive Ingredients: Distilled water, 20% Organic cane alcohol

PURPOSE

Use: Temporary relief of headache.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

WARNINGS

Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. Do not use if safety seal is broken or missing.

QUESTIONS

Questions? Call 866.642.2858 Uriel, East Troy, WI 53120 www.urielpharmacy.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

APIS ACONITUM 
apis aconitum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48951-1042
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	3 [hp_X]  in 1 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	3 [hp_X]  in 1 mL
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	12 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48951-1042-3	30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/01/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/01/2009

Labeler - Uriel Pharmacy Inc. (043471163)

Establishment
Name	Address	ID/FEI	Business Operations
Uriel Pharmacy Inc.		043471163	manufacture(48951-1042)