Label: UMCKA COLDCARE ALCOHOL-FREE- pelargonium sidoides liquid
- NDC Code(s): 53499-6271-8
- 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 October 25, 2024
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- Official Label (Printer Friendly)
- Active Ingredient
- Inactive Ingredient
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Dosage & Administration
Directions:
For best results, use at first sign of symptoms and continue to use for an additional 48 hours after symptoms cease.
Adults & children 13 years of age and older: Take 1.5 mL three times daily by mouth.
Children 6-12 years of age: Take 1 mL three times daily by mouth.
Children 1-5 years of age: Take 0.5 mL three times daily by mouth.
- Indications & Usage
- Purpose
- Warnings
- Ask Doctor
- Stop Use
- Pregnancy or Breast Feeding
- Keep out of reach of children.
- Overdose
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
UMCKA COLDCARE ALCOHOL-FREE
pelargonium sidoides liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53499-6271 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 59 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) MALTODEXTRIN (UNII: 7CVR7L4A2D) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53499-6271-8 1 in 1 CARTON 03/21/2023 02/28/2027 1 59 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 03/21/2023 02/28/2027 Labeler - Schwabe North America, Inc. (831153908) Establishment Name Address ID/FEI Business Operations Schwabe North America, Inc. 831153908 manufacture(53499-6271)