CODEINUM- codeine 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:

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)

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 - 168 pellets.

CAUTION: Federal law prohibits dispensing without prescription.

CODEINUM6X

CODEINUM 
codeine pellet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10191-1034
Route of AdministrationSUBLINGUALDEA ScheduleCII    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CODEINE ANHYDROUS (UNII: UX6OWY2V7J) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE ANHYDROUS6 [hp_X]
Inactive Ingredients
Ingredient NameStrength
LACTOSE (UNII: J2B2A4N98G)  
SUCROSE (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10191-1034-2165 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/10/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/10/2015
Labeler - Remedy Makers (018543582)

Revised: 3/2023
Document Id: f65ab6c0-1910-f6d5-e053-2995a90a34c2
Set id: 1a896d55-3107-478c-e054-00144ff88e88
Version: 16
Effective Time: 20230307
 
Remedy Makers