Umcka Original ColdCare: Homeopathic Product Information

UMCKA ORIGINAL COLDCARE — pelargonium sidoides root liquid
Schwabe North America

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.

Active Ingredient

PELARGONIUM SIDOIDES 1X

Inactive Ingredient

Ethyl Alcohol
Glycerin
Maltodextrin
Purified Water

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 12 years of age and older: Take 1.5 mL three times daily by mouth.

Children under 12 years of age: Consult a physician.

Indications & Usage

Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irritations: congestion, cough, hoarseness, sore throat.

Purpose

Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irritations: congestion, cough, hoarseness, sore throat.

Warnings

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 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 cough accompanied by excessive phlegm (mucus).

Stop Use

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, 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, consult a healthcare professional before use.

Keep out of reach of children

Keep out of reach of children.

Overdosage

In case of overdose, seek medical help or contact a Poison Control Center immediately.

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UMCKA ORIGINAL COLDCARE
pelargonium sidoides liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53499-5270
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PELARGONIUM SIDOIDES ROOT (PELARGONIUM SIDOIDES ROOT) PELARGONIUM SIDOIDES ROOT 1 [hp_X] in 30 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
MALTODEXTRIN
GLYCERIN
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53499-5270-4 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 30 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (53499-5270-4)
2 NDC:53499-5270-8 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
2 60 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (53499-5270-8)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 02/02/2009
Labeler — Schwabe North America (831153908)
Establishment
Name Address ID/FEI Operations
Schwabe North America, Inc 831153908 manufacture (53499-5270)

Revised: 09/2023 Schwabe North America

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