UMCKA THROAT- pelargonium sidoides root spray 
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 Throat Spray

Active Ingredient

Pelargonium Sidoides Root 1X

Inactive Ingredient

Ethyl Alcohol 8.5%

Glycerin

Maltodextrin

Menthol

Natural Flavor

Purified Water

Xylitol 

Purpose

Shortens duration and reduces severity of symptons associated with a sore throat.

Indications & Usage

Shortens duration and reduces severity of symptons associated with a sore throat.

Dosage & Administration

Directions:

Shake well before use.

For best results, use at first sign of symptoms; continue use for an additional 48 hours after symptoms cease.

Adults & children 12 years of age and older: apply 4 sprays into the back of the mouth 3 times daily.

Children under 12 years of age: consult a physician

Warning

Sore Throat warning: severe or persistent more than 2 days or if accompanied by a high fever, headache, nausea, vomiting, or rash maybe serious.

Consult a physician promptly.

Ask Doctor

Ask a doctor before use if you have a presistent or chronic cough that lasts, is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or is accompanied by excessive phelgm (mucus).

Stop Use

Stop use and ask a doctor if new symptoms occur, symptoms get worse, lasts more than 7 days, or 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.

Keep out of reach of children.

Keeo out of reach of children.

Overdoseage

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

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UMCKA THROAT 
pelargonium sidoides root spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-0533
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]  in 59 mL
Inactive Ingredients
Ingredient NameStrength
XYLITOL (UNII: VCQ006KQ1E)  
MENTHOL (UNII: L7T10EIP3A)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
SPEARMINT (UNII: J7I2T6IV1N)  
CHERRY JUICE (UNII: 4XTQ10247Y)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
Color    Score    
ShapeSize
FlavorSPEARMINT, CHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53499-0533-21 in 1 BOX09/01/201412/31/2021
159 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/01/201412/31/2021
Labeler - Schwabe North America, Inc (831153908)
Establishment
NameAddressID/FEIBusiness Operations
Schwabe North America, Inc.831153908manufacture(53499-0533)

Revised: 11/2020
 
Schwabe North America, Inc