Label: COMBINATION REMEDY 20 - INSOMNIA- coffea cruda, hyoscyamus niger, ignatia amara, passiflora incarnata, valeriana officinalis solution/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 69008-4070-1 - Packager: Warsan Homoeopathic Laboratories
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated December 25, 2017
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- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- ACTIVE INGREDIENT
- PURPOSE
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COMBINATION REMEDY 20 - INSOMNIA
coffea cruda, hyoscyamus niger, ignatia amara, passiflora incarnata, valeriana officinalis solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69008-4070 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 1 [hp_X] in 1 mL PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 1 [hp_X] in 1 mL ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 1 [hp_X] in 1 mL HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER 1 [hp_X] in 1 mL VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 1 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69008-4070-1 20 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 11/16/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 11/15/2017 Labeler - Warsan Homoeopathic Laboratories (645579772) Registrant - Warsan Homoeopathic Laboratories (645579772) Establishment Name Address ID/FEI Business Operations Warsan Homoeopathic Laboratories 645579772 manufacture(69008-4070) , pack(69008-4070) , label(69008-4070)