UMCKA ORIGINAL COLDCARE - pelargonium sidoides liquid 
Schwabe North America

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 Original ColdCare Drops

Active Ingredient

PELARGONIUM SIDOIDES 1X

Inactive Ingredient

ethyl alcohol
glycerin
maltodextrin
purified water

Dosage & Administation

Directions:

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

Adults & children 13 years of age and older: take 1.5 mL three times daily by mouth.

Children 12 years of age and under: consult a physician before use.

Indications & Usage

Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: congestion, cough, hoarseness, sore throat.

Purpose

Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: congestion, cough, hoarseness, sore throat.

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 Doctor

Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, a cough that is accompanied by excessive phlegm (mucus), been taking any medications, an allergy to plants of the Geraniaceae family.

Stop Use

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

Pregnancy or Breast-Feeding

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

Keep out of reach of children

Keep out of reach of children.

Overdosage

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

LGBN15270.A02-Umcka-Original-Liquid-1-oz.jpg

Add image transcription here...

UMCKA ORIGINAL COLDCARE  
pelargonium sidoides liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-6270
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 30 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53499-6270-41 in 1 CARTON04/06/2023
130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:53499-6270-81 in 1 CARTON04/06/2023
259.1 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/06/2023
Labeler - Schwabe North America (831153908)
Establishment
NameAddressID/FEIBusiness Operations
Schwabe North America, Inc831153908manufacture(53499-6270)

Revised: 4/2023
Document Id: 05428708-5162-47c5-90b5-fc12805e2789
Set id: 4b1fbd9f-9780-4274-9e02-d0ca96c19490
Version: 1
Effective Time: 20230406
 
Schwabe North America