Umcka ColdCare Day Plus Night: Homeopathic Product Information

UMCKA COLDCARE DAY PLUS NIGHT- umcka coldcare day plus night
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 Ingredients

Day: Pelargonium sidoides 1X

Night: Pelargonium sidoides 1X

Chamomilla recutila 2X

Humulus Lupulus 1X

Passiflora incarnate 1X

Inactive Ingredient

Day: Citric acid, ethyl alcohol, maltodextrin, natural flavors, silica, turmeric color, xylitol.
Night: Citric acid, ethyl alcohol, honey, lactose monohydrate, lou han guo, maltodextrin, natural flavor, silica, stevia leaf extract, turmeric color, xylitol.

Doage & Administration

Day: Dissolve contents of 1 packet in 4-6 ounces of hot water and sip while hot.

May also be dissolved in 4-6 ounces of cold water, which may be preferable for children

For best results use at the first sign of symptoms and continue to use for an additional 48 hours after symptoms cease.

ADULTS/CHILDREN 12 years of age and older: Take 1 paket 2 times daily

CHILDREN 6-11 years of age: Take 1 packet 2 times daily

CHILDREN UNDER 6 years of age: consult a physician

8 Packets per carton

Night: Dissolve contents of 1 packet in 4-6 ounces of hot water and sip while hot.

May also be dissolved in 4-6 ounces of cold water, which may be preferable for children

For best results use at the first sign of symptoms and continue to use for an additional 48 hours after symptoms cease.

ADULTS/CHILDREN 12 years of age and older: Take 1 packet 30 minutes prior to bedtime

CHILDREN 6-11 years of age: Take 1/2 packet 30 minutes prior to bedtime

CHILDREN UNDER 6 years of age: Consult a physician

4 Packets per carton

Indications & Usage

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


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

Purpose

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

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

Warnings

Day: Sore thoart warning: severe or presistent sore throat for than 2 days or if accompanied by high fever, headache, nausea, vomiting or rash may be serious.
Consult a physician promptly.

Night: Sore thoart warning: severe or presistent sore throat for than 2 days or if accompanied by high fever, headache, nausea, vomiting or rash may be serious.
Consult a physician promptly.

Ask Doctor

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

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

Stop Use

Day: Stop use and ask a doctor if new symptoms occur, symptoms worsent 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.

Night: Stop use and ask a doctor if new symptoms occur, symptoms worsent 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:

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

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

Keep out of reach of children.

Day: Keep out of reach of children.

Night: Keep out of reach of children.

Overdose

Day: In case of overdose, seek medical help or contact a Poison Control Center immediatley.

Night: In case of overdose, seek medical help or contact a Poison Control Center immediatley.

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UMCKA COLDCARE DAY PLUS NIGHT
umcka coldcare day plus night kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53499-1060
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53499-1060-1 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 POUCH 5 g
Part 2 1 POUCH 5 g
Part 1 of 2
UMCKA COLDCARE DAY
pelargonium sidoides root powder
Product Information
Item Code (Source) NDC:53499-1040
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] in 5 g
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
MALTODEXTRIN
SILICON DIOXIDE
TURMERIC
XYLITOL
ALCOHOL
Product Characteristics
Color Score
Shape Size
Flavor LEMON, CITRUS Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53499-1040-1 8 POUCH in 1 PACKAGE contains a POUCH
1 5 g in 1 POUCH This package is contained within the PACKAGE (53499-1040-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 12/09/2015
Part 2 of 2
UMCKA COLDCARE NIGHT
pelargonium sidoides root, chamomile, humulus lupulus whole, passiflora incarnata whole powder
Product Information
Item Code (Source) NDC:53499-1050
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] in 5 g
CHAMOMILE (CHAMOMILE) CHAMOMILE 2 [hp_X] in 5 g
HUMULUS LUPULUS WHOLE ( HUMULUS LUPULUS WHOLE) HUMULUS LUPULUS WHOLE 1 [hp_X] in 5 g
PASSIFLORA INCARNATA WHOLE ( PASSIFLORA INCARNATA WHOLE) PASSIFLORA INCARNATA WHOLE 1 [hp_X] in 5 g
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
HONEY
LACTOSE MONOHYDRATE
SIRAITIA GROSVENORII FRUIT
MALTODEXTRIN
SILICON DIOXIDE
STEVIA LEAF
TURMERIC
XYLITOL
ALCOHOL
Product Characteristics
Color Score
Shape Size
Flavor HONEY, LEMON Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53499-1050-1 4 POUCH in 1 PACKAGE contains a POUCH
1 5 g in 1 POUCH This package is contained within the PACKAGE (53499-1050-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 12/09/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 12/09/2015
Labeler — Schwabe North America, Inc. (831153908)
Establishment
Name Address ID/FEI Operations
Schwabe North America, Inc. 831153908 manufacture (53499-1060)

Revised: 11/2020 Schwabe North America, Inc.

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