UMCKA COLD FLU ORANGE- pelargonium sidoides, aconitum napellus, bry1onia, 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.

----------

Umcka Cold Flu Orange Chewables

Active Ingredient:

PELARGONIUM SIDOIDES

ACONITUM NAPELLUS

BRYONIA

EUCALYPTUS GLOBULUS

EUPATORIUM PERFOLIATUM

GELSEMIUM SEMPERVIRENS

IPECACUANHA

PHOSPHORUS.

Inactive Ingredients:

CITRIC ACID

LACTOSE

MAGNESIUM STEARATE

MALIC ACID

MANNITOL

MALTODEXTRIN

NATURAL ORANGE FLAVOR

STEARIC ACID

SORBITOL

XYLITOL.



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 4-5 times daily.
Children 6-11 years of age: take 1 chewable tablet 2-4 times daily.
Children under 6 years of age: consult a doctor.

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.  Helps loosen phlegm (mucus) to make coughs more productive.

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.  Helps loosen phlegm (mucus) to make coughs more productive.

Warnings:
Sore throat warning: if sore throat is severe, persists more than 2 days, is accompanied or followed by a fever, headache, rash, nausea or vomiting, consult a doctor promptly.

Ask a doctor before use if you have: persistent or chronic cough such as occurs with smoking, asthma or emphysema, a cough accompanied by excessive phlegm (mucus).

Stop use and ask a doctor if new symptoms occur, symptoms get worse or last more than 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 reach of children.

Ask the Doctor:

Ask a doctor before use if you have: persistent or chronic cough such as occurs with smoking, asthma or emphysema, a cough accompanied by excessive phlegm (mucus).

Stop use and ask a doctor if new symptoms occur, symptoms get worse or last more than 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.

Pregnancy or Breast Feeding:

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

Packaging Label. Principal Display Panel:

15161_03-UMCKA CF Orange Chew.jpg

15161_03-UMCKA CF Orange  Chew.jpg

15161_03-UMCKA CF Orange  Chew.jpg

UMCKA COLD FLU ORANGE 
pelargonium sidoides, aconitum napellus, bry1onia, eucalyptus globulus, eupatorium perfoliatum, gelsemium sempervirens, ipecacuanha, phosphorus tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-5161
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 TOP2 [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
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
ColorwhiteScoreno score
ShapeROUND (C) Size16mm
FlavorORANGE (NATURAL ORANGE FLAVOR) Imprint Code UMCKA
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53499-5161-02 in 1 CARTON08/24/201110/31/2018
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/24/201110/31/2018
Labeler - Schwabe North America, Inc (831153908)
Establishment
NameAddressID/FEIBusiness Operations
Schwabe North America, Inc.831153908manufacture(53499-5161)

Revised: 9/2017
 
Schwabe North America, Inc