Umcka Cold Flu Sugar Free Orange: Homeopathic Product Information

UMCKA COLD FLU SUGAR FREE ORANGE- pelargonium sidoides root, aconitum napellus, eucalyptus globulus leaf, bryonia alba root, eupatorium perfoliatum flowering top, gelsemium sempervirens root, phosphorus and ipecac 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 Ingredients

´╗┐Pelargonium sidoides 1X

Aconitum napellus 4X

Eucalyptus globulus 2X

Bryonia 4X

Eupatoriaum perfoliatum 6X

Gelsemium sempervirens 4X

Phosphorus 6X

Ipecacuanha 3X

Inactive Ingredients

Citric acid

Ethyl alcohol

Glycerin

Lactose monohydrate

Malic acid

Maltodextrin

Natural flavor

Potassium sorbate

Purified water

Sorbitol

Dosage and 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.

Adults and children 12 years of age and older: take 1 1/2 teaspoon (tsp) (7.5 mL) three times daily.

Children 6-11 years of age: take 1 teaspoon (5 mL) three times daily.

Children under 6 years of age: consult a physician.

Indication and Usage:

Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations, and temporarily relieves flu symptoms: chills/fever, congestion, cough, headache, hoarseness, minor aches/pains, sore throat, stuffy nose, sneezing/runny nose.

Purpose

Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations, and temporarily relieves flu symptoms: chills/fever, congestion, cough, headache, hoarseness, minor aches/pains, sore throat, stuffy nose, sneezing/runny nose.

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 Section

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

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 you are 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 Poison Control Center immediately.

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UMCKA COLD FLU SUGAR FREE ORANGE
pelargonium sidoides, aconitum napellus, bryonia alba, eucalyptus globulus, eupatorium perfoliatum, gelsemium sempervirens, ipecacuanha, phosphorus syrup
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53499-9149
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
ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS 4 [hp_X] in 120 mL
EUCALYPTUS GLOBULUS LEAF (EUCALYPTUS GLOBULUS LEAF) EUCALYPTUS GLOBULUS LEAF 2 [hp_X] in 120 mL
BRYONIA ALBA ROOT (BRYONIA ALBA ROOT) BRYONIA ALBA ROOT 4 [hp_X] in 120 mL
EUPATORIUM PERFOLIATUM FLOWERING TOP (EUPATORIUM PERFOLIATUM FLOWERING TOP) EUPATORIUM PERFOLIATUM FLOWERING TOP 6 [hp_X] in 120 mL
GELSEMIUM SEMPERVIRENS ROOT (GELSEMIUM SEMPERVIRENS ROOT) GELSEMIUM SEMPERVIRENS ROOT 4 [hp_X] in 120 mL
PHOSPHORUS (PHOSPHORUS) PHOSPHORUS 6 [hp_X] in 120 mL
IPECAC (IPECAC) IPECAC 3 [hp_X] in 120 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
ALCOHOL
GLYCERIN
LACTOSE MONOHYDRATE
MALIC ACID
MALTODEXTRIN
WATER
SORBITOL
POTASSIUM SORBATE
Product Characteristics
Color Score
Shape Size
Flavor ORANGE (NATURAL ORANGE FLAVOR) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53499-9149-5 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 120 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (53499-9149-5)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 10/14/2017 07/31/2023
Labeler — Schwabe North America, Inc. (831153908)
Establishment
Name Address ID/FEI Operations
Schwabe North America, Inc. 831153908 manufacture (53499-9149)

Revised: 03/2022 Schwabe North America, Inc.

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