UMCKA COLD FLU SUGAR FREE ORANGE- pelargonium sidoides, aconitum napellus, bryonia alba, eucalyptus globulus, eupatorium perfoliatum, gelsemium sempervirens, ipecacuanha, phosphorus syrup

Umcka Cold Flu Sugar Free Orange by

Drug Labeling and Warnings

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

Drug Details [pdf]

UMCKA Cold + Flu fructose Free Orange Syrup

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 (0.05%)

Glycerin

Lactose monohydrate

Malic acid

Maltodextrin

Natural orange flavor

Purified water

Sorbitol

DOSAGE & ADMINISTRATION

Dosage and Administration:

Nature's Way Brand:

Directions: For best results, use at first sign of symptoms and continue to use for an additional 48 hours after symptoms cease. 

Use only with enclosed dosage cup.

Adults and children 12 years of age and older: take 1 1/2 teaspoon (7.5 mL) 3 times daily.

Children 6-11 years of age: take 1 teaspoon (5 mL) 3 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

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 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 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 the reach of children.

Overdose:

In case of overdose, seek medical help or contact a Poison Control Center immediately.

Ask the 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 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.

OTC-Pregnancy or Breast Feeding Section:

If pregnant or breast-feeding, ask a healthcare professional before use. 

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

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]  in 120 mL
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	4 [hp_X]  in 120 mL
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6)	EUCALYPTUS GLOBULUS LEAF	2 [hp_X]  in 120 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	4 [hp_X]  in 120 mL
EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E)	EUPATORIUM PERFOLIATUM FLOWERING TOP	6 [hp_X]  in 120 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	4 [hp_X]  in 120 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	6 [hp_X]  in 120 mL
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	3 [hp_X]  in 120 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MALIC ACID (UNII: 817L1N4CKP)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	ORANGE (NATURAL ORANGE FLAVOR)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-9149-5	1 in 1 CARTON	10/14/2017
1		120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/14/2017

Labeler - Schwabe North America, Inc. (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe North America, Inc.		831153908	manufacture(53499-9149)