OPIUM- raw opium gum pellet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Remedy Makers

מסלול נתינה (של תרופות):

SUBLINGUAL

סוג מרשם:

PRESCRIPTION DRUG

מצב אישור:

unapproved homeopathic

מאפייני מוצר

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 determined that the 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 medications
out of reach of
children. If symptoms persist for 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)
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. 166 - 169 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:10191-1089
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_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-
1089-2
166 in 1 VIAL, GLASS; Type 0: Not a Combination
Product
07/09/2015
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
unapproved
homeopathic
07/09/2015
LABELER -
Remedy Makers (018543582)
Revised: 3/2023