UMCKA COLDCARE ALCOHOL-FREE- pelargonium sidoides liquid 
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 ColdCare Alcohol-Free Drops

Active Ingredient:

PELARGONIUM SIDOIDES 1x

Inactive Ingredients:  Citric acid, ethyl alcohol, glycerin, maltodextrin, potassium sorbate, purified water, sorbitol.

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 1.5 mL 3 times daily by mouth.

Children 6-11 years of age: take 1 mL 3 times daily by mouth.

Children under 6 years of age: consult a physician.

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

OTC 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: severe or persistent sore throat for more than 2 days or if accompanied by high fever, headache, nausea, vomiting or rash may be serions.

Consult a physician promptly.

Keep out of the reach of children.

ASK DOCTOR:

Ask a doctor before use if you have a 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 get 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.

OVERDOSE WARNING:

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

OTC  Pregnancy or Breast Feeding

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

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UMCKA COLDCARE ALCOHOL-FREE 
pelargonium sidoides liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-5271
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53499-5271-41 in 1 CARTON02/02/2009
130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:53499-5271-81 in 1 CARTON02/02/2009
260 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/02/2009
Labeler - Schwabe North America, Inc. (831153908)
Establishment
NameAddressID/FEIBusiness Operations
Schwabe North America, Inc.831153908manufacture(53499-5271)

Revised: 9/2019
Document Id: c55bf239-6615-4678-abfc-ef476069db28
Set id: 5c647ae9-6c14-4661-aba3-53e9e4756edc
Version: 7
Effective Time: 20190913
 
Schwabe North America, Inc.