Umcka Cold Flu Orange: Homeopathic Product Information

UMCKA COLD FLU ORANGE- pelargonium sidoides root, aconitum napellus, bryonia alba root, eucalyptus globulus leaf, eupatorium perfoliatum flowering top, gelsemium sempervirens root, ipecac and phosphorus tablet, chewable
Schwabe North Amertica, 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

ACONITUM NAPELLUS 4X

EUCALYPTUS GLOBULUS 2X

BRYONIA 4X

EUPATORIUM PERFOLIATUM 6X

GELSEMIUM SEMPERVIRENS 4X

PHOSPHORUS 6X

IPECACUANHA 3X

Inactive Ingredients

CITRIC ACID

LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MALIC ACID

MALTODEXTRIN
MANNITOL
NATURAL FLAVOR

SORBITOL
STEARIC ACID
XYLITOL

Dosage & Administration

Chew or dissolve tablets in the mouth.

Do not swallow whole.

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 chewable tablet 3 times daily.
Children 6-11 years of age: take 1 chewable tablet 2 times daily.
Children under 6 years of age: consult a physician.

Indications & Usage

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

Purpose

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

Warnings

Sore throat warning: severe or persistent sore throat for more than 2 days or if accompanied by high fever, headache, nausea, vimiting or rash may be serious.

Consult a physician promptly..

Ask Doctor

Ask a doctor before use if you have: persistent or chronic cough that lasts, is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema or is a cough accompanied by excessive phlegm (mucus).

Stop use

Stop use and ask a doctor 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

Keep out of reach of children.

Overdose

In case of overdoese, seek medical help or contact a Poison Control Center immediatley.

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UMCKA COLD FLU ORANGE
pelargonium sidoides, aconitum napellus, bryonia, eucalyptus globulus, eupatorium perfoliatum, gelsemium sempervirens, ipecacuanha, phosphorus tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53499-9161
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]
ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS 4 [hp_X]
BRYONIA ALBA ROOT (BRYONIA ALBA ROOT) BRYONIA ALBA ROOT 4 [hp_X]
EUCALYPTUS GLOBULUS LEAF (EUCALYPTUS GLOBULUS LEAF) EUCALYPTUS GLOBULUS LEAF 2 [hp_X]
EUPATORIUM PERFOLIATUM FLOWERING TOP (EUPATORIUM PERFOLIATUM FLOWERING TOP) EUPATORIUM PERFOLIATUM FLOWERING TOP 6 [hp_X]
GELSEMIUM SEMPERVIRENS ROOT (GELSEMIUM SEMPERVIRENS ROOT) GELSEMIUM SEMPERVIRENS ROOT 4 [hp_X]
IPECAC (IPECAC) IPECAC 3 [hp_X]
PHOSPHORUS (PHOSPHORUS) PHOSPHORUS 6 [hp_X]
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MALIC ACID
MALTODEXTRIN
MANNITOL
SORBITOL
STEARIC ACID
XYLITOL
Product Characteristics
Color white Score no score
Shape ROUND (C) Size 16mm
Flavor ORANGE (NATURAL ORANGE FLAVOR) Imprint Code UMCKA
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53499-9161-0 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (53499-9161-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 09/08/2017
Labeler — Schwabe North Amertica, Inc. (831153908)
Establishment
Name Address ID/FEI Operations
Schwabe North America, Inc. 831153908 manufacture (53499-9161)

Revised: 10/2021 Schwabe North Amertica, Inc.

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