Cold Relief Day Plus Night

Cold Relief Day Plus Night
SPL v4
SPL
SPL Set ID 9b063242-ffd6-48f8-af1e-14bcea5247ec
Route
ORAL
Published
Effective Date 2025-07-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pelargonium Sidoides Root (1 [hp_X]) Chamomile (2 [hp_X]) Humulus Lupulus Whole Passiflora Incarnata Whole
Inactive Ingredients
Citric Acid Monohydrate Maltodextrin Silicon Dioxide Turmeric Xylitol Honey Lactose Monohydrate Siraitia Grosvenorii Fruit Stevia Leaf

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2024-05-22

Description

Cold Relief Day: Pelargonium sidoides 1X Cold Relief Night: Pelargonium sidoides 1X Chamomilla recutita 2X Humulus lupulus 1X Passiflora incarnata 1X

Purpose

Cold Relief Day: Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chest congestion, nasal congestion, cough, hoarseness, sore throat Cold Relief Night: Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chest congestion, nasal congestion, cough, hoarseness, sore throat


Medication Information

Purpose

Cold Relief Day: Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chest congestion, nasal congestion, cough, hoarseness, sore throat

Cold Relief Night: Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chest congestion, nasal congestion, cough, hoarseness, sore throat

Description

Cold Relief Day: Pelargonium sidoides 1X Cold Relief Night: Pelargonium sidoides 1X Chamomilla recutita 2X Humulus lupulus 1X Passiflora incarnata 1X

Section 51945-4

Overdose

Cold Relief Day: In case of overdose, seek medical help or contact a Poison Control Center right away.

Cold Relief Night: In case of overdose, seek medical help or contact a Poison Control Center right away.

Stop Use

Cold Relief Day: 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.

Cold Relief Night: 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.

Warnings

Cold Relief Day: 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.

Cold Relief Night: 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 Doctor

Cold Relief Day: Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, a cough that is accompanied by excessive phlegm (mucus), been taking any medications, an allergy to plants of the Geraniaceae family.

Cold Relief Night: Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, a cough that is accompanied by excessive phlegm (mucus), been taking any medications, an allergy to plants of the Geraniaceae family.

Active Ingredient

Cold Relief Day:

Pelargonium sidoides 1X

Cold Relief Night:

Pelargonium sidoides 1X

Chamomilla recutita 2X

Humulus lupulus 1X

Passiflora incarnata 1X

Inactive Ingredient

Cold Relief Day: Citric Acid, Maltodextrin, Natural Flavor, Silica, Turmeric Color, Xylitol.



Cold Relief Night: Citric Acid, Honey, Lactose Monohydrate, Lou Han Guo, Maltodextrin, Natural Flavor, Silica, Stevia Leaf Extract, Turmeric Color, Xylitol.

Indications & Usage

Cold Relief Day: Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chest congestion, nasal congestion, cough, hoarseness, sore throat

Cold Relief Night: Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chest congestion, nasal congestion, cough, hoarseness, sore throat

Dosage & Administration

Directions

Cold Relief 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 with Umcka® Cold Relief Hot Drink Night Formula at the first sign of symptoms and continue to use for an additional 48 hours after symptoms cease.

Adults/Children 13 years of age and older: Take 1 packet two times daily

Children 6-12 years of age: Take 1 packet daily

Children under 6 years of age: Consult a doctor

Cold Relief 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 with Umcka® Cold Relief Hot Drink Day Formula at the first sign of symptoms and continue to use for an additional 48 hours after symptoms cease.

Adults/Children 13 years of age and older: Take 1 packet nightly 30-60 minutes before bed

Children 6-12 years of age: Take 1 packet nightly 30-60 minutes before bed

Children under 6 years of age: Consult a doctor

Pregnancy Or Breast Feeding

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

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

Keep Out of Reach of Children.

Cold Relief Day: Keep out of reach of children.

Cold Relief Night: Keep out of reach of children.


Structured Label Content

Section 51945-4 (51945-4)

Purpose

Cold Relief Day: Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chest congestion, nasal congestion, cough, hoarseness, sore throat

Cold Relief Night: Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chest congestion, nasal congestion, cough, hoarseness, sore throat

Overdose

Cold Relief Day: In case of overdose, seek medical help or contact a Poison Control Center right away.

Cold Relief Night: In case of overdose, seek medical help or contact a Poison Control Center right away.

Stop Use

Cold Relief Day: 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.

Cold Relief Night: 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.

Warnings

Cold Relief Day: 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.

Cold Relief Night: 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 Doctor

Cold Relief Day: Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, a cough that is accompanied by excessive phlegm (mucus), been taking any medications, an allergy to plants of the Geraniaceae family.

Cold Relief Night: Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, a cough that is accompanied by excessive phlegm (mucus), been taking any medications, an allergy to plants of the Geraniaceae family.

Active Ingredient

Cold Relief Day:

Pelargonium sidoides 1X

Cold Relief Night:

Pelargonium sidoides 1X

Chamomilla recutita 2X

Humulus lupulus 1X

Passiflora incarnata 1X

Inactive Ingredient

Cold Relief Day: Citric Acid, Maltodextrin, Natural Flavor, Silica, Turmeric Color, Xylitol.



Cold Relief Night: Citric Acid, Honey, Lactose Monohydrate, Lou Han Guo, Maltodextrin, Natural Flavor, Silica, Stevia Leaf Extract, Turmeric Color, Xylitol.

Indications & Usage

Cold Relief Day: Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chest congestion, nasal congestion, cough, hoarseness, sore throat

Cold Relief Night: Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chest congestion, nasal congestion, cough, hoarseness, sore throat

Dosage & Administration

Directions

Cold Relief 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 with Umcka® Cold Relief Hot Drink Night Formula at the first sign of symptoms and continue to use for an additional 48 hours after symptoms cease.

Adults/Children 13 years of age and older: Take 1 packet two times daily

Children 6-12 years of age: Take 1 packet daily

Children under 6 years of age: Consult a doctor

Cold Relief 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 with Umcka® Cold Relief Hot Drink Day Formula at the first sign of symptoms and continue to use for an additional 48 hours after symptoms cease.

Adults/Children 13 years of age and older: Take 1 packet nightly 30-60 minutes before bed

Children 6-12 years of age: Take 1 packet nightly 30-60 minutes before bed

Children under 6 years of age: Consult a doctor

Pregnancy Or Breast Feeding (Pregnancy or Breast feeding)

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

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

Keep Out of Reach of Children. (Keep out of reach of children.)

Cold Relief Day: Keep out of reach of children.

Cold Relief Night: Keep out of reach of children.


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