UMCKA COLDCARE CHERRY- pelargonium sidoides 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 Coldcare Cherry Chewable Tablet

Active Ingredient

PELARGONIUM SIDOIDES 1X

Inactive Ingredient

CITRIC ACID

MAGNESIUM STEARATE

MALIC ACID

MALTODEXTRIN

MANNITOL

NATURAL FLAVOR

SODIUM CROSCARMELLOSE

SORBITOL

STEARIC ACID

XYLITOL

Dosage & Adminstration

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 three times daily.
Children 6-11 years of age: Take 1 chewable tablet two times daily.
Children under 6 years of age: Consult a physician.

Indications & Usage

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

Purpose

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

Warning

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

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

Overdose

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

LGBN15144.02-Z-Umcka-Coldcare-Cherry-20-chew-tabs.jpg

Add image transcription here...

UMCKA COLDCARE CHERRY 
pelargonium sidoides tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-5144
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]
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALIC ACID (UNII: 817L1N4CKP)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MANNITOL (UNII: 3OWL53L36A)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
SORBITOL (UNII: 506T60A25R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
Colorpink (CHERRY TABLET) Scoreno score
ShapeROUND (C) Size16mm
FlavorCHERRY (NATURAL CHERRY FLAVOR) Imprint Code C
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53499-5144-02 in 1 CARTON08/24/201106/30/2025
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/24/201106/30/2025
Labeler - Schwabe North America, Inc (831153908)
Establishment
NameAddressID/FEIBusiness Operations
Schwabe North America, Inc.831153908manufacture(53499-5144)

Revised: 10/2023
Document Id: 9ec958c6-3a00-4708-ac47-68037c988d91
Set id: 493ccfce-5d41-4962-8201-54292936c73c
Version: 11
Effective Time: 20231002
 
Schwabe North America, Inc