OPIUM- raw opium gum pellet

OPIUM by

Drug Labeling and Warnings

OPIUM by is a Homeopathic medication manufactured, distributed, or labeled by Remedy Makers. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CONTROLLED SUBSTANCE

Opium

INDICATIONS & USAGE

ILEUS, FEAR, SLEEPLESSNES, VERTIGO, TRAUMA, OR OTHER INDICATIONS

WARNINGS

WARNING:Keep this and all medications out of reach of children.

INDICATIONS & USAGE

INDICATIONS: To be use according to standard homeopathic indications,or as prescribed by a licensed physician.

Free from yeast, wheat, corn, and soy.

WARNINGS

WARNING SECTION: Use only if cap and seal are unbroken. If symptoms persist for more than 3 days, contact your physician or pharmacist. Do not take if you are pregnant or nursing a baby. Store tightly closed in a cool, dark place. Made according to The Homeopathic Pharmacopoeia of the United State by: Remedy Makers, Pomona, CA 91768 

DOSAGE & ADMINISTRATION

USUAL DOSAGE: Dissolve 3 or 4 pellets in mouth or tongue as prescribed by a licensed  physician. Children 2 years and younger take 1/2 the adult dose

INACTIVE INGREDIENT

80% SUCROSE / 20% LACTOSE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OPIUM 
raw opium gum pellet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 10191-1093
Route of Administration	SUBLINGUAL	DEA Schedule	CII

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OPIUM (UNII: 37M3MZ001L) (OPIUM - UNII:37M3MZ001L)	OPIUM	30 [hp_C]

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)
LACTOSE (UNII: J2B2A4N98G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10191-1093-2	137 in 1 VIAL, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/21/2001

Labeler - Remedy Makers (018543582)