UMCKA COLD FLU BERRY CHEWABLE- pelargonium sidoides, aconitum napellus, bryonia, eucalyptus globulus, eupatorium perfoliatum, gelsemium sempervirens, ipecacuanha, 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.

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Umcka Cold + Flu Berry Chewable Tablet

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

Directions

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.

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 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).

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-2347
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PELARGONIUM SIDOIDES ROOT (UNII: H6J53HEX8E) (PELARGONIUM SIDOIDES ROOT - UNII:H6J53HEX8E) PELARGONIUM SIDOIDES ROOT1 [hp_X]
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS4 [hp_X]
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT4 [hp_X]
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6) EUCALYPTUS GLOBULUS LEAF2 [hp_X]
EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP6 [hp_X]
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT4 [hp_X]
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC3 [hp_X]
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS6 [hp_X]
Inactive Ingredients
Ingredient NameStrength
ANNATTO (UNII: 6PQP1V1B6O)  
BEET JUICE (UNII: IOZ32L9H3O)  
CARAMEL (UNII: T9D99G2B1R)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALIC ACID (UNII: 817L1N4CKP)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MANNITOL (UNII: 3OWL53L36A)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
SORBITOL (UNII: 506T60A25R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
Colorpink (pink with pinkish-purple specks) Scoreno score
ShapeROUND (C) Size16mm
FlavorBERRY (NATURAL BERRY FLAVOR) Imprint Code C
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53499-2347-01 in 1 CARTON08/27/201812/31/2024
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/27/201812/31/2024
Labeler - Schwabe North America, Inc. (831153908)
Establishment
NameAddressID/FEIBusiness Operations
Schwabe North America, Inc831153908manufacture(53499-2347)

Revised: 7/2023
Document Id: 6ac94e79-e9f3-4072-be63-842ea20171e1
Set id: c761598b-9f78-471a-83a3-8a391841e948
Version: 7
Effective Time: 20230712
 
Schwabe North America, Inc.