Label: UMCKA COLDCARE LEMON- pelargonium sidoides powder
- NDC Code(s): 53499-5146-0
- 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 May 2, 2023
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- Official Label (Printer Friendly)
- Active Ingredient
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Dosage & Administration
Dissolve contents of 1 packet in 4-6 ounces of hot water and sip while hot.
May also be dissolved in 4-6 ounces of cold water, which may be preferable for children.
For best results, use at the first sign of symptoms and continue to use for an additional 48 hours after symptoms cease.
Adults and children 13 years of age and older: Take 3 times daily.Children 6-12 years of age: Take 2 times daily.
Children under 6 years of age: Consult a physician.
- Warnings
- Ask Doctor
- Stop Use
- Pregnant or breast feeding
- Keep out of reach of children.
- Overdose
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
UMCKA COLDCARE LEMON
pelargonium sidoides powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53499-5146 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 5 g Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) MALTODEXTRIN (UNII: 7CVR7L4A2D) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TURMERIC (UNII: 856YO1Z64F) XYLITOL (UNII: VCQ006KQ1E) Product Characteristics Color Score Shape Size Flavor LEMON (NATURAL LEMON FLAVOR) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53499-5146-0 10 in 1 CARTON 07/01/2009 1 5 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/01/2009 Labeler - Schwabe North America, Inc. (831153908) Establishment Name Address ID/FEI Business Operations Schwabe North America, Inc. 831153908 manufacture(53499-5146) Establishment Name Address ID/FEI Business Operations ProSolutions, Inc. 070769782 label(53499-5146) , pack(53499-5146)