CODEINUM: Homeopathic Product Information

CODEINUM- codeine anhydrous 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”

INDICATIONS:

ITCHING WITH WARMTH SPASMODIC COUGH, 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 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 or 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.

Other Information:

Contains approx. 172 — 173 pellets.

Questions or comments:

(877) REM4YOU Fax (909) 594-4205, Pomona, Ca. 91768 USA www.remedymakers.com

CAUTION: Federal law prohibits dispensing without prescription.

CODEINUM12X

CODEINUM
codeine pellet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10191-1036
Route of Administration SUBLINGUAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CODEINE ANHYDROUS (CODEINE ANHYDROUS) CODEINE ANHYDROUS 12 [hp_X]
Inactive Ingredients
Ingredient Name Strength
LACTOSE
SUCROSE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10191-1036-2 172 PELLET in 1 VIAL, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 07/15/2015
Labeler — Remedy Makers (018543582)

Revised: 07/2015 Remedy Makers

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