Country: United States
Language: English
Source: NLM (National Library of Medicine)
OPIUM (UNII: 37M3MZ001L) (OPIUM - UNII:37M3MZ001L)
Remedy Makers
SUBLINGUAL
PRESCRIPTION DRUG
unapproved homeopathic
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._ ---------- CII WARNING: "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 Remedy Makers 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 (UNII: 37M3MZ001L) (OPIUM - UNII:37M3MZ001L) OPIUM 30 [hp_X] INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH SUCROSE (UNII: C151H8M554) LACTOSE (UNII: J2B2A4N98G) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:10191- 1086-2 165 in 1 VIAL, GLASS; Type 0: Not a Combination Product 07/08/2015 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: 3/2023 Read the complete document