Label: COUGH AND BRONCHIAL- aconitum napellus, bryonia alba root, calcium cation, spongia officinalis skeleton, roasted, tin syrup
- NDC Code(s): 53499-1293-5, 53499-1293-9
- Packager: Schwabe North America
- 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 September 8, 2023
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- Active Ingredient
- Inactive Ingredient
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INGREDIENTS AND APPEARANCE
COUGH AND BRONCHIAL
aconitum napellus, bryonia alba root, calcium cation, spongia officinalis skeleton, roasted, tin syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53499-1293 Route of Administration 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 Inactive Ingredients Ingredient Name Strength ACACIA (UNII: 5C5403N26O) BARLEY MALT (UNII: R3NBG8914U) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCROSE (UNII: C151H8M554) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53499-1293-5 1 in 1 CARTON 02/08/2023 1 120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:53499-1293-9 1 in 1 CARTON 02/08/2023 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 02/08/2023 Labeler - Schwabe North America (831153908) Establishment Name Address ID/FEI Business Operations Schwabe Mexico, S.A. de C.V. 812805901 manufacture(53499-1293)