Umcka ColdCare Childrens Cherry: Homeopathic Product Information

UMCKA COLDCARE CHILDRENS CHERRY- pelargonium sidoides root syrup
Schwabe North America, Inc

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 Ingredients

ARONIA JUICE

CITRIC ACID

ETHYL ALCOHOL

FRUCTOSE

GLYCERIN

MALTODEXTRIN

NATURAL FLAVOR

POTASSIUM SORBATE

PURIFIED WATER

Dosage & Administration

For best results, use at first sign of symptoms and continue to use for an additional 48 hours after symptoms cease.

Shake well before each use.

Use only with enclosed dosage cup.

Children 13 years of age and older: Take 1.5 teaspoons (tsp) (7.5mL) three times daily.
Children 6-12 years of age: Take 1 teaspoon (5mL) three 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 irritations: congestion, cough, hoarseness, sore throat.

Purpose

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

Warnings

Sore throat warning: Severe or persistent sore throat for more than 2 days of 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 asthma, chronic bronchitis, or emphysema or is accompanied by excessive phlegm (mucus).

Stop Use

Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better in 7 days, fever worsens or lasts more than 3 days, cough lasts more than 7 days or occurs with rash or persistent headache.

Pregnancy or Breast Feeding

If pregnant or breast-feeding, ask a healthcare professional before use.

Keep out of reach of children

Keep out of reach of children

Overdose

In case of overdose, seek medical help or contact a Posion Control Center immediatley.

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UMCKA COLDCARE CHILDRENS CHERRY
pelargonium sidoides syrup
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53499-0165
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 120 mL
Inactive Ingredients
Ingredient Name Strength
ARONIA MELANOCARPA FRUIT JUICE
ANHYDROUS CITRIC ACID
ALCOHOL
FRUCTOSE
MALTODEXTRIN
WATER
POTASSIUM SORBATE
GLYCERIN
Product Characteristics
Color Score
Shape Size
Flavor CHERRY (NATURAL CHERRY FLAVOR) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53499-0165-5 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 120 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (53499-0165-5)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 09/01/2009
Labeler — Schwabe North America, Inc (831153908)
Establishment
Name Address ID/FEI Operations
Schwabe North America, Inc 831153908 manufacture (53499-0165)

Revised: 10/2021 Schwabe North America, Inc

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