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

Active Ingredients:

Pelargonium sidoides 1X

Aconitum napellus 4X

Eucalyptus globulus 2X

Bryonia 4X

Eupatoriaum perfoliatum 2X

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 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.

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 doctor.

Indication and Usage:

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

Purpose:

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 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, cough lasts more than 7 days or occurs with rash or persistent headache, fever worsens or lasts more than 3 days.

These could be signs of a serious condition.

Keep Out of Reach of Children:

Keep out of the 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, cough lasts more than 7 days or occurs with rash or persistent headache, fever worsens or lasts more than 3 days.

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.

UMCKA Cold + Flu Fructose Free Orange Syrup

UMCKA_15149 CF Orange_05.jpg

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53499-5149
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	4 [hp_X] in 120 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	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
EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E)	EUPATORIUM PERFOLIATUM FLOWERING TOP	2 [hp_X] in 120 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	4 [hp_X] in 120 mL
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	3 [hp_X] in 120 mL
PELARGONIUM SIDOIDES ROOT (UNII: H6J53HEX8E) (PELARGONIUM SIDOIDES ROOT - UNII:H6J53HEX8E)	PELARGONIUM SIDOIDES ROOT	1 [hp_X] in 120 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	6 [hp_X] in 120 mL

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53499-5149-5	1 in 1 CARTON	01/01/2006	01/31/2019
1		120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/01/2006	01/31/2019

Labeler - Schwabe North America, Inc (831153908)

Name	Address	ID/FEI	Business Operations
Establishment
Schwabe North America, Inc.		831153908	manufacture(53499-5149)

Revised: 10/2017

Document Id: 7c188c48-159e-47a3-983e-132d25fcb61f

Set id: e634c8a5-4f9e-4cf5-ad1c-cc6f1c1506be

Version: 4

Effective Time: 20171006

Schwabe North America, Inc