OPIUM- raw opium gum pellet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OPIUM (UNII: 37M3MZ001L) (OPIUM - UNII:37M3MZ001L)

Available from:

Remedy Makers

Administration route:

SUBLINGUAL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

unapproved homeopathic

Summary of Product characteristics

OPIUM- RAW OPIUM GUM PELLET
REMEDY MAKERS
_Disclaimer: 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._
----------
CII
WARNING:
"The FDA has not deternined that this product is safe, effective and
not misbranded for
its intended use".
INDICATION:
VERTIGO, 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 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 advise 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 [phone] Pomona, CA. 91768 USA
www.remedymakers.com
OTHER INFORMATION:
Contains approx. 160 - 164 pellets.
CAUTION:
Federal law prohibits dispensing without prescription.
OPIUM
Remedy Makers
raw opium gum pellet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION
DRUG
ITEM CODE (SOURCE)
NDC:10191-1082
ROUTE OF ADMINISTRATION
SUBLINGUAL
DEA SCHEDULE
CII
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
OPIUM (UNII: 37M3MZ001L) (OPIUM - UNII:37M3MZ001L)
OPIUM
6 [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-
1082-2
160 in 1 VIAL, GLASS; Type 0: Not a Combination
Product
07/07/2015
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
unapproved
homeopathic
07/06/2015
LABELER -
Remedy M