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.

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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.

OPIUM6C

OPIUM
raw opium gum pellet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:10191-1089
Route of Administration	SUBLINGUAL	DEA Schedule	CII

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OPIUM (UNII: 37M3MZ001L) (OPIUM - UNII:37M3MZ001L)	OPIUM	6 [hp_C]

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10191-1089-2	166 in 1 VIAL, GLASS; Type 0: Not a Combination Product	07/09/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		07/09/2015

Labeler - Remedy Makers (018543582)