Umcka Allergy and Sinus: Homeopathic Product Information

UMCKA ALLERGY AND SINUS- pelargonium sidoides root, hydrastis canadensis whole, potassium chloride, sanguinaria canadensis root, pulsatilla vulgaris and silicon dioxide tablet, chewable
Schwabe North American, 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

Hydrastis canadensis 6X

Kali muriaticum 3X

Sanguinaria canadensis 6X

Pulsatilla 6X

Silicea 6X

Inactive Ingredient

Citric Acid

Lactose monohydrate

Magnesium Sterate

Malic Acid

Maltodextrin

Mannitol

Natural Flavors

Sodium Croscarmellose

Sorbitol

Sour Cherry Powder

Stearic acid

Xylitol

Purpose

Shortens duration and reduces severity of symptoms associated with the common cold and throat, nasal, bronchial irritations and temporarily relieves allergy and sinus symptoms; cough, congestion, promotes sinus drainage, helps decongest sinus openings and passages, headache, sneezing/runny nose, burning, itchy eyes, sore throat, shrinks swollen nasal membranes, sinus presssure.

Indications and Usage Section

Shortens duration and reduces severity of symptoms associated with the common cold and throat, nasal, bronchial irritations and temporarily relieves allergy and sinus symptoms; cough, congestion, promotes sinus drainage, helps decongest sinus openings and passages, headache, sneezing/runny nose, burning, itchy eyes, sore throat, shrinks swollen nasal membranes, sinus presssure.

Dosage & Administration

Chew or dissolve tablets in 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 occur.

Adults & Children 12 years of age and older: Take 1 chewable tablet 3 times daily.

Children 6-11 of age: Take 1 chewable tablet times daily.

Children under 6 years of age: Consult a physician

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 maybe serious.

Consult a physician promptly.

Ask a Doctor Section

Ask a doctor before use if you have a persistant or chronic cough that lasts, is chronic such as ocurs 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 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.

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 ALLERGY AND SINUS
pelargonium sidoides root, hydrastis canadensis whole, potassium chloride, sanguinaria canadensis root, pulsatilla vulgaris, silicon dioxide tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53499-3194
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]
HYDRASTIS CANADENSIS WHOLE (HYDRASTIS CANADENSIS WHOLE) HYDRASTIS CANADENSIS WHOLE 6 [hp_X]
POTASSIUM CHLORIDE (POTASSIUM CATION) POTASSIUM CHLORIDE 3 [hp_X]
SANGUINARIA CANADENSIS ROOT (SANGUINARIA CANADENSIS ROOT) SANGUINARIA CANADENSIS ROOT 6 [hp_X]
PULSATILLA VULGARIS (ANEMONE PULSATILLA) PULSATILLA VULGARIS 6 [hp_X]
SILICON DIOXIDE (SILICON DIOXIDE) SILICON DIOXIDE 6 [hp_X]
Inactive Ingredients
Ingredient Name Strength
CHERRY
CITRIC ACID MONOHYDRATE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MALIC ACID
MALTODEXTRIN
MANNITOL
CROSCARMELLOSE SODIUM
SORBITOL
STEARIC ACID
XYLITOL
Product Characteristics
Color white Score no score
Shape ROUND Size 16mm
Flavor CHERRY Imprint Code C
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53499-3194-2 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 (53499-3194-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 06/01/2018
Labeler — Schwabe North American, Inc. (831153908)
Establishment
Name Address ID/FEI Operations
Schwabe North America, Inc. 831153908 manufacture (53499-3194)

Revised: 10/2021 Schwabe North American, Inc.

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