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

Umcka Cold Flu Orange by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

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:

CITRIC ACID

LACTOSE MONOHYDRATE

MAGNESIUM STEARATE

MALIC ACID

MANNITOL

MALTODEXTRIN

NATURAL FLAVOR

STEARIC ACID

SORBITOL

XYLITOL

DOSAGE & ADMINISTRATION

Dosage and Administration:

Nature's Way Brand:

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

Indications 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/stuff nose, cough, headache, hoarseness, minor aches/pains, sneezing/runny nose, sore throat. 

PURPOSE

Purpose:
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/stuff 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 high fever, headache, nausea, vimiting 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 a cough accompanied by excessive phlegm (mucus).

Stop use and ask a doctor 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.

ASK DOCTOR

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 a cough accompanied by excessive phlegm (mucus).

Stop use and ask a doctor 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:
Keep out of reach of children.

PREGNANCY OR BREAST FEEDING

Pregnancy or Breast Feeding:
If pregnant or breast-feeding, ask a healthcare professional before use.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UMCKA COLD FLU ORANGE 
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: 53499-9161
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALIC ACID (UNII: 817L1N4CKP)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MANNITOL (UNII: 3OWL53L36A)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	white	Score	no score
Shape	ROUND (C)	Size	16mm
Flavor	ORANGE (NATURAL ORANGE FLAVOR)	Imprint Code	UMCKA
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-9161-0	2 in 1 CARTON	09/08/2017
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		09/08/2017

Labeler - Schwabe North Amertica, Inc. (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe North America, Inc.		831153908	manufacture(53499-9161)