Label: UMCKA COLDCARE ALCOHOL-FREE- pelargonium sidoides liquid
- NDC Code(s): 53499-5271-4, 53499-5271-8
- 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.
Updated September 13, 2019
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- ACTIVE INGREDIENT
DOSAGE & ADMINISTRATION
Nature's Way Brand:
Directions: For best results, use at 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 1.5 mL 3 times daily by mouth.
Children 6-11 years of age: take 1 mL 3 times daily by mouth.
Children under 6 years of age: consult a physician.
Uses: Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: congestion, cough, hoarseness, sore throat.
Sore throat warning: severe or persistent sore throat for more than 2 days or if accompanied by high fever, headache, nausea, vomiting or rash may be serions.
Consult a physician promptly.
Ask a doctor before use if you have a persistent or chronic cough that 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 worsen or do not get better within 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.
In case of overdose, seek medical help or contact a Poison Control Center immediately.
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
UMCKA COLDCARE ALCOHOL-FREE
pelargonium sidoides liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53499-5271 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 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:53499-5271-4 1 in 1 CARTON 02/02/2009 1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 2 NDC:53499-5271-8 1 in 1 CARTON 02/02/2009 2 60 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 02/02/2009 Labeler - Schwabe North America, Inc. (831153908) Establishment Name Address ID/FEI Business Operations Schwabe North America, Inc. 831153908 manufacture(53499-5271)