Label: UMCKA ORIGINAL COLDCARE- pelargonium sidoides liquid
- NDC Code(s): 53499-6270-4, 53499-6270-8
- 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 April 6, 2023
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- Active Ingredient
- Inactive Ingredient
- Dosage & Administation
- Indications & Usage
- Purpose
- Warnings
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- Pregnancy or Breast-Feeding
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- Overdosage
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INGREDIENTS AND APPEARANCE
UMCKA ORIGINAL COLDCARE
pelargonium sidoides liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53499-6270 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PELARGONIUM SIDOIDES ROOT (UNII: H6J53HEX8E) (PELARGONIUM SIDOIDES ROOT - UNII:H6J53HEX8E) PELARGONIUM SIDOIDES ROOT 1 [hp_X] in 30 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) MALTODEXTRIN (UNII: 7CVR7L4A2D) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53499-6270-4 1 in 1 CARTON 04/06/2023 1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 2 NDC:53499-6270-8 1 in 1 CARTON 04/06/2023 2 59.1 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/06/2023 Labeler - Schwabe North America (831153908) Establishment Name Address ID/FEI Business Operations Schwabe North America, Inc 831153908 manufacture(53499-6270)