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]

SPL UNCLASSIFIED SECTION

CII

WARNING:

"The FDA has not determined that this product is safe, effect and not misbranded for its intended use."

INDICATION

VERTIGO, DIARREA, PAIN OR OTHER INDICATIONS

WARNING:

Use only if cap and seal are unbroken. Keep this and all medication out of reach of children. If symptoms persist more than 3 days or worsen, discontinue (STOP) use and consult your physician. As with any drug. If you are pregnant or nursing(breast-feeding) a baby, seek the advice of a health professional before using this product. Store tightly closed in a cool area.

Directions (adult/children)

Dissolve 3 or 4 pellets in mouth under tongue 3 times a day or as directed by a physician. Children 2 years and older take 1/2 adult dose.

Inactive Ingredients:

Lactose and Sucrose. Free from yeast, wheat, corn and soy.

Questions or comments:

(877) REM4YOU Fax ((909) 594-4205 Pomona, CA 91768 USA www.remedymakers.com

Other Information:

Contains approx. 160 - 173 pellets.

WARNINGS AND PRECAUTIONS

CAUTION: Federal law prohibits dispensing without prescription

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OPIUM 
raw opium gum pellet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 10191-1081
Route of Administration	SUBLINGUAL	DEA Schedule	CII

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OPIUM (UNII: 37M3MZ001L) (OPIUM - UNII:37M3MZ001L)	OPIUM	3 [hp_X]

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10191-1081-2	160 in 1 VIAL, GLASS; Type 0: Not a Combination Product	05/21/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/21/2015

Labeler - Remedy Makers (018543582)