OPIUM

OPIUM- opium 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

“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.

CAUTION: Federal law prohibits dispensing without prescription.

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 (OPIUM) OPIUM 30 [hp_X]

Inactive Ingredients Ingredient Name Strength SUCROSE LACTOSE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:10191-1086-2 165 PELLET in 1 VIAL, GLASS None

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

Labeler — Remedy Makers (018543582)

Revised: 07/2015 Remedy Makers