OPIUM- raw opium gum pellet

OPIUM by

Drug Labeling and Warnings

OPIUM by is a Prescription 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 the product is safe, effective and not misbranded for its intended use"

INDICATION:

VERITGO, DIARRHEA, 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 for more than 3 days or wosen, discountinue (STOP) use and consult your physician. As with any drug. If ypu are pregnant or nursing (breast-feeding) a baby, seek the advise of a health professional before using this product. Store tightly closed in a cool area.

Directions (adult/children)

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

Other Information:

Contains approx. 165 - 166 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: 10191-1086
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_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: 10191-1086-2	165 in 1 VIAL, GLASS; Type 0: Not a Combination Product	07/08/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/08/2015

Labeler - Remedy Makers (018543582)