Umcka ColdCare Sugar Free Grape: Homeopathic Product Information

UMCKA COLDCARE SUGAR FREE GRAPE — 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

CITRIC ACID

ETHYL ALCOHOL

GLYCERIN

MALTODEXTRIN

NATURAL FLAVOR

POTASSIUM SORBATE

PURIFIED WATER

RED CABBAGE JUICE COLOR

SORBITOL

Dosage and Administration

Directions

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.

Adults & children 12 years of age and older: Take 1 1/2 teaspoon (tsp) (7.5 mL) 3 times daily.
Children 6-11 years of age: Take 1 teaspoon (tsp) (5mL) 3 times daily.
Children under 6 years of age: Consult a physician.

Indications & Usage

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

Purpose

Shortens duration and reduces severity of symptoms associated with common colds and throat/sinus/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 a 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).

Stope 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, 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.

Keep out of reach of children

Keep out of reach of children.

Overdose

In case of overdose, seeek medical help or contact a Poison Control Center immediatley.

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UMCKA COLDCARE SUGAR FREE GRAPE
pelargonium sidoides syrup
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53499-5794
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
ANHYDROUS CITRIC ACID
ALCOHOL
MALTODEXTRIN
WATER
CABBAGE
SORBITOL
GLYCERIN
POTASSIUM SORBATE
Product Characteristics
Color Score
Shape Size
Flavor GRAPE (NATURAL GRAPE FLAVOR) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53499-5794-5 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 120 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (53499-5794-5)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 09/01/2006
Labeler — Schwabe North America, Inc (831153908)
Establishment
Name Address ID/FEI Operations
Schwabe North America 831153908 manufacture (53499-5794)

Revised: 11/2023 Schwabe North America, Inc

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