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.
Updated October 14, 2019
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- ACTIVE INGREDIENT
DOSAGE & ADMINISTRATION
Dosage and Administration:
Nature's Way Brand:
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 12 years of age and older: take 3 times daily.
Children 6-11 years of age: take 2 times daily.
Children under 6 years of age: consult a physician.
Indications and Usage:
Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritation: congestion, cough, hoarseness, sore throat.
Sore throat warning: Severe or persistent sore throat for more than 2 days or if accompanied by a high fever, headache, nausea, vomiting or rash may be serious.
Consult a physician promptly.
Ask a Doctor:
Ask a doctor before use if you have a persistent or chronic cough thats lasts, is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema, or is accompanied by excessive phlegm (mucus).
Stop use and ask a doctor if new symptoms occur, symptoms get worse or last more than 7 days, fever worsens or lasts more than 3 days, cough lasts more than 7 days or occurs with rash or persistent headache.
These could be signs of a serious condition.
Pregnancy or Breast Feeding:
If pregnant or breast-feeding, ask a healthcare professional before use.
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
UMCKA COLDCARE LEMON
pelargonium sidoides powder
Product 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)