Label: BRONCHIAL AND BREATHING AIDE- aconitum napellus, calcium sulfide, spongia officinalis skeleton, roasted, tin tablet
- NDC Code(s): 53499-9498-2
- Packager: Schwabe North America, Inc
- 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 July 26, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Inactive Ingredients
- Purpose
- Indications & Usage
- Dosage & Administration
- Warning
- Ask Doctor
- Stop Use
- Pregnancy or Breast Feeding
- Keep out of reach of children
- Overdosage
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BRONCHIAL AND BREATHING AIDE
aconitum napellus, calcium sulfide, spongia officinalis skeleton, roasted, tin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53499-9498 Route of Administration SUBLINGUAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 3 [hp_X] CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 12 [hp_X] SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED 3 [hp_X] Tin (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) Tin 12 [hp_X] Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Product Characteristics Color white (B;T) Score no score Shape ROUND (BT) Size 8mm Flavor Imprint Code B;T Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53499-9498-2 1 in 1 BOX 04/01/2017 03/31/2027 1 100 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/01/2017 03/31/2027 Labeler - Schwabe North America, Inc (831153908) Establishment Name Address ID/FEI Business Operations Schwabe Mexico SA DE CV 812805901 manufacture(53499-9498)