OPIUM- raw opium gum pellet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
OPIUM (UNII: 37M3MZ001L) (OPIUM - UNII:37M3MZ001L)
Available from:
Remedy Makers
Administration route:
SUBLINGUAL
Prescription type:
PRESCRIPTION DRUG
Authorization status:
unapproved homeopathic
Authorization number:
10191-1081-2

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.

----------

WARNING:

"The FDA has not determined that this product is safe, effect and not misbranded for its intended use."

INDICATION

VERTIGO, DIARREA, 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 advice 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 ((909) 594-4205 Pomona, CA 91768 USA www.remedymakers.com

Other Information:

Contains approx. 160 - 173 pellets.

CAUTION: Federal law prohibits dispensing without prescription

OPIUM

Remedy Makers

raw opium gum pellet

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:10 19 1-10 8 1

Route of Administration

SUBLINGUAL

DEA Sche dule

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O PIUM (UNII: 37M3MZ0 0 1L) (OPIUM - UNII:37M3MZ0 0 1L)

OPIUM

3 [hp_X]

Inactive Ingredients

Ingredient Name

Stre ng th

SUCRO SE (UNII: C151H8 M554)

LACTO SE (UNII: J2B2A4N9 8 G)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:10 19 1-10 8 1-2

16 0 in 1 VIAL, GLASS; Type 0 : No t a Co mbinatio n Pro duct

0 5/21/20 15

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

0 5/21/20 15

Labeler -

Remedy Makers (018543582)

Revised: 7/2015

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