Label: UMCKA COLDCARE ALCOHOL FREE CHERRY- pelargonium sidoides syrup
- NDC Code(s): 53499-5273-5, 53499-5273-7, 53499-5273-9
- 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 March 8, 2019
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- ACTIVE INGREDIENT
DOSAGE & ADMINISTRATION
Dosage and Administration:
Nature's Way Brand:
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 1/2 teaspoon (7.5mL) 3 times daily.
Children 6-11 years of age: take 1 teaspoon (5mL) 3 times daily.
Children under 6 years of age: consult a physician.
Indications and Usage Section:
Shortens duration and reduces severity of symptoms associated with the common cold and throat/sinus/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 serious.
Consult a physician promptly.
Ask the Doctor:
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 worsen or do not get better within 7 days, fever worsens or lasts more than 3 days, or 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.
- Package Label. Principal Display Panel:15793 Umcka ColdCare Cherry Alcohol Free 8 pz 15273 Umcka ColdCare Cherry Alcohol Free 4 oz15301 Umcka ColdCare Cherry Alcohol Free 10 ml Sample size
INGREDIENTS AND APPEARANCE
UMCKA COLDCARE ALCOHOL FREE CHERRY
pelargonium sidoides syrup
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53499-5273 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 240 mL Inactive Ingredients Ingredient Name Strength ARONIA MELANOCARPA FRUIT JUICE (UNII: D2EVP827PJ) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ALCOHOL (UNII: 3K9958V90M) FRUCTOSE (UNII: 6YSS42VSEV) MALTODEXTRIN (UNII: 7CVR7L4A2D) POTASSIUM CITRATE (UNII: EE90ONI6FF) WATER (UNII: 059QF0KO0R) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) Product Characteristics Color Score Shape Size Flavor CHERRY (NATURAL CHERRY FLAVOR) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53499-5273-5 1 in 1 CARTON 01/01/2006 1 120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:53499-5273-9 1 in 1 CARTON 01/01/2006 2 240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:53499-5273-7 10 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2006 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/01/2006 Labeler - Schwabe North America, Inc (831153908) Establishment Name Address ID/FEI Business Operations Schwabe North America, Inc 831153908 manufacture(53499-5273)