SPL v13
SPL
SPL Set ID cbf06050-23e1-464c-8aca-f752717c2de1
Route
ORAL
Published
Effective Date 2024-10-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Umcka CC Day: Pelargonium sidoides 1X Umcka CC Night: Pelargonium sidoides 1X                          Chamomilla recutila 2X                         Humulus Lupulus 1X                         Passiflora incarnate 1X


Medication Information

Warnings and Precautions

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

Indications and Usage

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

Dosage and Administration

Directions Umcka CC 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 packet 2 times daily Children 6-11 years of age: Take 1 packet 2 times daily Children under 6 years of age: Consult a doctor Umcka CC 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 doctor

Description

Umcka CC Day: Pelargonium sidoides 1X Umcka CC Night: Pelargonium sidoides 1X                          Chamomilla recutila 2X                         Humulus Lupulus 1X                         Passiflora incarnate 1X

Section 34088-5

Umcka CC Day: In case of overdose, seek medical help or contact a Poison Control Center immediately. Umcka CC Night: In case of overdose, seek medical help or contact a Poison Control Center immediately.

Section 50565-1

Umcka CC Day: Keep out of reach of children. Umcka CC Night: Keep out of reach of children.

Section 50566-9

Umcka CC Day: 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. Umcka CC Night: 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.

Section 50569-3

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

Section 51727-6

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

Section 51945-4

Add image transcription here... Add image transcription here... Add image transcription here...

Section 53414-9

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

Section 55105-1

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

Section 55106-9

Umcka CC Day: Pelargonium sidoides 1X Umcka CC Night: Pelargonium sidoides 1X                          Chamomilla recutila 2X                         Humulus Lupulus 1X                         Passiflora incarnate 1X


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Directions Umcka CC 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 packet 2 times daily Children 6-11 years of age: Take 1 packet 2 times daily Children under 6 years of age: Consult a doctor Umcka CC 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 doctor

Warnings and Precautions (34071-1)

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

Section 34088-5 (34088-5)

Umcka CC Day: In case of overdose, seek medical help or contact a Poison Control Center immediately. Umcka CC Night: In case of overdose, seek medical help or contact a Poison Control Center immediately.

Section 50565-1 (50565-1)

Umcka CC Day: Keep out of reach of children. Umcka CC Night: Keep out of reach of children.

Section 50566-9 (50566-9)

Umcka CC Day: 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. Umcka CC Night: 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.

Section 50569-3 (50569-3)

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

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Add image transcription here... Add image transcription here... Add image transcription here...

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

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

Section 55106-9 (55106-9)

Umcka CC Day: Pelargonium sidoides 1X Umcka CC Night: Pelargonium sidoides 1X                          Chamomilla recutila 2X                         Humulus Lupulus 1X                         Passiflora incarnate 1X


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