Label: COUGH AND BRONCHIAL NIGHTTIME SYRUP- aconitum napellus, bryonia root, calcium cation, spongia officinalis skeleton, roasted, tin, medicago sativa leaf, oat, arabica coffee bean syrup
- NDC Code(s): 68466-1009-5, 68466-1009-9
- Packager: Schwabe Mexico S.A. DE C.V.
- 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 March 3, 2023
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INGREDIENTS AND APPEARANCE
COUGH AND BRONCHIAL NIGHTTIME SYRUP
aconitum napellus, bryonia root, calcium cation, spongia officinalis skeleton, roasted, tin, medicago sativa leaf, oat, arabica coffee bean syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68466-1009 Route of Administration ORAL, ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 3 [hp_X] in 120 mL BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 3 [hp_X] in 120 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 6 [hp_C] in 120 mL SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED 3 [hp_X] in 120 mL TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) TIN 6 [hp_C] in 120 mL MEDICAGO SATIVA LEAF (UNII: HY3L927V6M) (MEDICAGO SATIVA LEAF - UNII:HY3L927V6M) MEDICAGO SATIVA LEAF 1 [hp_X] in 120 mL OAT (UNII: Z6J799EAJK) (OAT - UNII:Z6J799EAJK) OAT 1 [hp_X] in 120 mL ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 6 [hp_X] in 120 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) BARLEY MALT (UNII: R3NBG8914U) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCROSE (UNII: C151H8M554) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68466-1009-5 1 in 1 CARTON 03/03/2023 1 120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:68466-1009-9 1 in 1 CARTON 03/03/2023 2 240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/03/2023 Labeler - Schwabe Mexico S.A. DE C.V. (812805901) Establishment Name Address ID/FEI Business Operations Schwabe Mexico S.A. DE C.V. 812805901 manufacture(68466-1009)