UMCKA COLDCARE MINT CHEWABLE pelargonium sidoides tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
PELARGONIUM SIDOIDES ROOT (UNII: H6J53HEX8E) (PELARGONIUM SIDOIDES ROOT - UNII:H6J53HEX8E)
Available from:
Schwabe North America, Inc.
INN (International Name):
PELARGONIUM SIDOIDES ROOT
Composition:
PELARGONIUM SIDOIDES ROOT 1 [hp_X]
Prescription type:
OTC DRUG
Authorization status:
unapproved homeopathic

UMCKA COLDCARE MINT CHEWABLE- 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.

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Umcka ColdCare Mint Chewable

Active Ingredient:

PELARGONIUM SIDOIDES

Inactive Ingredients:

MAGNESIUM STEARATE

MALTODEXTRIN

MANNITOL

MODIFIED CELLULOSE GUM

NATURAL MENTHOL FLAVOR

NATURAL SPEARMINT FLAVOR

SORBITOL

STEARIC ACID

XYLITOL.

Dosage and Administration:

Nature's Way Brand:

Directions :

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 4-5 times daily.

Children 6-11 years of age: take 1 chewable tablet 2-4 times daily.

Children under 6 years of age: consult a doctor.

Indications and Usage:

Shortens duration and reduces severity of symptoms associated with the common cold and

throat/sinus/bronchial infections: congestion, cough, headache, hoarseness, minor aches, sore throat.

Purpos e:

Shortens duration and reduces severity of upper respiratory symptoms.

Warnings :

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 before use if you have: persistent or chronic cough such as occurs with smoking, asthma

or emphysema, a cough accompanied by excessive phlegm (mucus).

Stop use and ask a doctor if new symptoms occur, symptoms get worse or last more than 7 days, cough

lasts more than 7 days or occurs with rash or persistent headache, fever worsens or lasts more than 3

days.

These could be signs of a serious condition.

Keep out of Reach of Children:

Keep out of reach of children.

Ask the Doctor:

Ask a doctor before use if you have: persistent or chronic cough such as occurs with smoking, asthma

or emphysema, a cough accompanied by excessive phlegm (mucus).

Stop use and ask a doctor if new symptoms occur, symptoms get worse or last more than 7 days, cough

lasts more than 7 days or occurs with rash or persistent headache, fever worsens or lasts more than 3

days.

These could be signs of a serious condition.

Pregnancy or Breast Feeding:

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

UMCKA Mint Chewables (15145)

Packaging Label. Principal Display Panel:

15145_03 Umcka CC Mint Chew.jpg

UMCKA COLDCARE MINT CHEWABLE

pelargonium sidoides tablet, chewable

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:5349 9 -5145

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PELARGO NIUM SIDO IDES RO O T (UNII: H6 J53HEX8 E) (PELARGONIUM SIDOIDES ROOT

- UNII:H6 J53HEX8 E)

PELARGONIUM SIDOIDES

ROOT

1 [hp_X]

Inactive Ingredients

Ingredient Name

Stre ng th

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

Schwabe North America, Inc.

MANNITO L (UNII: 3OWL53L36 A)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

MENTHO L (UNII: L7T10 EIP3A)

SO RBITO L (UNII: 50 6 T6 0 A25R)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

XYLITO L (UNII: VCQ0 0 6 KQ1E)

Product Characteristics

Color

white (WHITE TABLET)

S core

no sco re

S hap e

ROUND (UMCKA)

S iz e

16 mm

Flavor

MENTHOL (NATURAL MENTHOL FLAVOR) , SPEARMINT (NATURAL SPEARMINT FLAVOR)

Imprint Code

UMCKA;

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:5349 9 -5145-0

2 in 1 CARTON

10 /11/20 11

0 4/30 /20 18

1

10 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

10 /11/20 11

0 4/30 /20 18

Labeler -

Schwabe North America, Inc. (831153908)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Schwabe No rth America, Inc.

8 311539 0 8

ma nufa c ture (5349 9 -5145)

Revised: 10/2016

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