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

Umcka Cold Flu Berry Chewable by

Drug Labeling and Warnings

Umcka Cold Flu Berry Chewable by is a Homeopathic medication manufactured, distributed, or labeled by Schwabe North America, Inc., Schwabe North America, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Umcka Cold+ Flu Chewable Berry Tablets

Active Ingredient:

PELARGONIUM SIDOIDES 1X

ACONITUM NAPELLUS 4X

BRYONIA 4X

EUCALYPTUS GLOBULUS 2X

EUPATORIUM PERFOLIATUM 6X

GELSEMIUM SEMPERVIRENS 4X

IPECACUANHA 3X

PHOSPHORUS 6X

Inactive Ingredients:

ANNATTO

BEET JUICE

LACTOSE MONOHYDRATE

CARAMEL COLOR

MAGNESIUM STEARATE

MALIC ACID

MALTODEXTRIN

MANNiTOL

SODIUM CROSCARMELLOSE

NATURAL BERRY FLAVOR

SORBITOL

STEARIC ACID

XYLITOL

DOSAGE & ADMINISTRATION

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 and Usage:

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

WARNINGS

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 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 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.

Keep out of Reach of Children:

Keep out of reach of children.

Ask the 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 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.

12347 UMCKA Cold + Flu Chewable tablets

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PELARGONIUM SIDOIDES ROOT (UNII: H6J53HEX8E) (PELARGONIUM SIDOIDES ROOT - UNII:H6J53HEX8E)	PELARGONIUM SIDOIDES ROOT	1 [hp_X]
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	4 [hp_X]
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	4 [hp_X]
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6)	EUCALYPTUS GLOBULUS LEAF	2 [hp_X]
EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E)	EUPATORIUM PERFOLIATUM FLOWERING TOP	6 [hp_X]
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	4 [hp_X]
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	3 [hp_X]
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	6 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
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
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	Marketing Start Date	Marketing End Date
1	NDC: 53499-2347-0	1 in 1 CARTON	08/27/2018
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

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	Business Operations
Schwabe North America, Inc		831153908	manufacture(53499-2347)