UMCKA MENTHOL- pelargonium sidoides syrup 
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 Mint-Menthol Syrup

Active Ingredient

PELARGONIUM SIDOIDES 1X

Inactive Ingredient

ETHYL ALCOHOL

FRUCTOSE

GLYCERIN

MALTODEXTRIN

MENTHOL

NATURAL FLAVOR

PURIFIED WATER

Dosage & Administration

Directions

For best results, use at first sign of symptoms.

Continue to use for an additional 48 hours after symptoms cease. 

Use only with enclosed dosage cup.

Adults & children 12 years of age and older: Take 1 1/2 teaspoon (tsp) (7.5 mL) 3 times daily.

Children under 12 years of age: Consult a physician.

Indications & Usage

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

Purpose

Shortens duration and reduces severity of symptoms associated with common colds 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 a high fever, headache, nausea, vomiting, or rash may be serious.

Consult a physician promptly.

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

Stop use and ask the doctor if new symptoms occur, symptoms worsen or do not get better within 7 days, fever worsens or lasts more than 3 days, or 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 Poison Control Center immediately. 

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UMCKA MENTHOL 
pelargonium sidoides syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-5272
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 120 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
FRUCTOSE (UNII: 6YSS42VSEV)  
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMENTHOL (NATURAL MENTHOL FLAVOR) , SPEARMINT (NATURAL SPEARMINT FLAVOR) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53499-5272-51 in 1 CARTON01/01/2006
1120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:53499-5272-91 in 1 CARTON01/01/2006
2240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/01/2006
Labeler - Schwabe North America, Inc (831153908)
Establishment
NameAddressID/FEIBusiness Operations
Schwabe North America, Inc831153908manufacture(53499-5272)

Revised: 10/2023
Document Id: ca028c50-ded5-4fbf-9c58-feb3adbdbceb
Set id: a3d94c70-3d62-44a8-bdae-39b07e8e0e36
Version: 10
Effective Time: 20231026
 
Schwabe North America, Inc