Umcka ColdCare Mint Chewable: Homeopathic Product Information

UMCKA COLDCARE MINT CHEWABLE- pelargonium sidoides root 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.

Active Ingredient

PELARGONIUM SIDOIDES 1X

Inactive Ingredients

ETHYL ALCOHOL

MAGNESIUM STEARATE
MALTODEXTRIN
MANNITOL

MENTHOL

NATURAL FLAVOR
SODIUM CROSCARMELLOSE

SORBITOL
STEARIC ACID
XYLITOL

Dosage & Administration

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/nasal/bronchial infections: congestion, cough, hoarseness, sore throat.

Purpose

Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial infections: 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 high fever, headache, nausea, vomiting or rash may be serious.

Consult physician promptly.

Ask Doctor

Ask a doctor before use if you have a persistent or chronic cough thats 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 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 reach of children

Keep out reach of children

Overdose

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

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UMCKA COLDCARE MINT CHEWABLE
pelargonium sidoides tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53499-9145
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PELARGONIUM SIDOIDES ROOT (PELARGONIUM SIDOIDES ROOT) PELARGONIUM SIDOIDES ROOT 1 [hp_X]
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
MALTODEXTRIN
MANNITOL
CROSCARMELLOSE SODIUM
MENTHOL
SORBITOL
STEARIC ACID
XYLITOL
ALCOHOL
Product Characteristics
Color white (WHITE TABLET) Score no score
Shape ROUND (C) Size 16mm
Flavor MENTHOL (NATURAL MENTHOL FLAVOR) , SPEARMINT (NATURAL SPEARMINT FLAVOR) Imprint Code C
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53499-9145-0 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (53499-9145-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 12/29/2016
Labeler — Schwabe North America, Inc (831153908)
Establishment
Name Address ID/FEI Operations
Schwabe North America, Inc. 831153908 manufacture (53499-9145)

Revised: 10/2021 Schwabe North America, Inc

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