Umcka Cold Flu Berry Chewable: Homeopathic Product Information

UMCKA COLD FLU BERRY CHEWABLE- 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 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

ACONITUM NAPELLUS 4X

EUCALYPTUS GLOBULUS 2X

BRYONIA 4X

EUPATORIUM PERFOLIATUM 6X

GELSEMIUM SEMPERVIRENS 4X

PHOSPHORUS 6X

IPECACUANHA 3X

Inactive Ingredients

ANNATTO
BEET JUICE
CARAMEL COLOR

LACTOSE MONOHYDRATE
MAGNESIUM STEARATE

MALIC ACID

MALTODEXTRIN

MANNiTOL

NATURAL FLAVORS

SODIUM CROSCARMELLOSE

SORBITOL

STEARIC ACID

XYLITOL

Dosage and 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/nasal/bronchial irritations, and temporarily relieves flu symptoms: chills/fever, congestion/stuffy 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/nasal/bronchial irritations, and temporarily relieves flu symptoms: chills/fever, congestion/stuffy nose, cough, headache, hoarseness, minor aches/pains, sneezing/runny nose, sore throat.

Warning

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 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 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, 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 BERRY CHEWABLE
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:53499-2347
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
ANNATTO
BEET JUICE
CARAMEL
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MALIC ACID
MALTODEXTRIN
MANNITOL
CROSCARMELLOSE SODIUM
SORBITOL
STEARIC ACID
XYLITOL
Product Characteristics
Color pink (pink with pinkish-purple specks) Score no score
Shape ROUND (C) Size 16mm
Flavor BERRY (NATURAL BERRY FLAVOR) Imprint Code C
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53499-2347-0 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (53499-2347-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 08/27/2018
Labeler — Schwabe North America, Inc. (831153908)
Establishment
Name Address ID/FEI Operations
Schwabe North America, Inc 831153908 manufacture (53499-2347)

Revised: 10/2021 Schwabe North America, Inc.

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