SPL v10
SPL
SPL Set ID c267c869-631e-44e4-8cbe-a4da5f305ace
Route
ORAL
Published
Effective Date 2024-10-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Umcka CC Cherry Syrup: Pelargonium sidoides 1X Soothing Hot Drink-Lemon Packet: Pelargonium sidoides 1X


Medication Information

Warnings and Precautions

Umcka CC Cherry Syrup: Sore throat warning: severe or persistent 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. Soothing Hot Drink-Lemon Packet: Sore Throat Warning: severe or persistent 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 Cherry Syrup:  Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irritations: congestion, cough, hoarseness, sore throat. Soothing Hot Drink-Lemon Packet: Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irritations: congestion, cough, headache, hoarseness, sore throat.

Dosage and Administration

Directions Umcka CC Cherry Syrup:  For best results, use at first sign of symptoms and continue to use for an additional 48 hours after symptoms cease.  Use only with enclosed dosage cup. Adults & children 12 years of age and older:  Take 1 1/2 teaspoon (tsp) (7.5 mL) 3 times daily Chidlren 6 - 11 years of age:  Take 1 teaspoon (5 mL) 3 times daily Children under 6 years of age:  Consult a physician Soothing Hot Drink-Lemon Packet: 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 symtoms cease. Adults & chilrden 12 years of age and older:  Take 3-4 times daily Children 6-11 years of age:  Take 2-3 times daily Children under 6 years of age:  Consult a physician

Description

Umcka CC Cherry Syrup: Pelargonium sidoides 1X Soothing Hot Drink-Lemon Packet: Pelargonium sidoides 1X

Section 34088-5

Umcka CC Cherry Syrup: In case of overdose, seek medical help or contact a Poison Control Center immediately. Soothing Hot Drink-Lemon Packet:  In case of overdose, seek medical help or contact a Poison Control Center immediately.

Section 50565-1

Umcka CC Cherry Syrup:  Keep out of reach of children. Soothing Hot Drink-Lemon Packet:  Keep out of reach of children.

Section 50566-9

Umcka CC Cherry Syrup: 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. Soothing Hot Drink-Lemon Packet: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 Cherry Syrup: Ask a doctor before use if you have a persistent or chronic cough that lasts, is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema or is accompanied by excessive phlegm (mucus). Soothing Hot Drink-Lemon Packet:  Ask a doctor before use if you have a persistent or chronic cough that lasts, is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema or is accompanied by excessive phlegm (mucus).

Section 51727-6

Umcka CC Cherry Syrup: aronia juice, citric acid, ethyl alcohol, fructose, glycerin, maltodextrin, natural flavors, potassium sorbate, purified water Soothing Hot Drink-Lemon Packet:citric acid, maltodextrin, natural flavor, silica, turmeric (color), xylitol

Section 51945-4

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Section 53414-9

Umcka CC Cherry Syrup:  If pregnant or breast-feeding, ask a healthcare professional before use. Soothing Hot Drink-Lemon Packet: If pregnant or breast-feeding, ask a healthcare professional before use.

Section 55105-1

Umcka CC Cherry Syrup: Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irritations: congestion, cough, hoarseness, sore throat. Soothing Hot Drink-Lemon Packet: Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irritations: congestion, cough, headache, hoarseness, sore throat.

Section 55106-9

Umcka CC Cherry Syrup: Pelargonium sidoides 1X Soothing Hot Drink-Lemon Packet: Pelargonium sidoides 1X


Structured Label Content

Indications and Usage (34067-9)

Umcka CC Cherry Syrup:  Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irritations: congestion, cough, hoarseness, sore throat. Soothing Hot Drink-Lemon Packet: Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irritations: congestion, cough, headache, hoarseness, sore throat.

Dosage and Administration (34068-7)

Directions Umcka CC Cherry Syrup:  For best results, use at first sign of symptoms and continue to use for an additional 48 hours after symptoms cease.  Use only with enclosed dosage cup. Adults & children 12 years of age and older:  Take 1 1/2 teaspoon (tsp) (7.5 mL) 3 times daily Chidlren 6 - 11 years of age:  Take 1 teaspoon (5 mL) 3 times daily Children under 6 years of age:  Consult a physician Soothing Hot Drink-Lemon Packet: 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 symtoms cease. Adults & chilrden 12 years of age and older:  Take 3-4 times daily Children 6-11 years of age:  Take 2-3 times daily Children under 6 years of age:  Consult a physician

Warnings and Precautions (34071-1)

Umcka CC Cherry Syrup: Sore throat warning: severe or persistent 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. Soothing Hot Drink-Lemon Packet: Sore Throat Warning: severe or persistent 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 Cherry Syrup: In case of overdose, seek medical help or contact a Poison Control Center immediately. Soothing Hot Drink-Lemon Packet:  In case of overdose, seek medical help or contact a Poison Control Center immediately.

Section 50565-1 (50565-1)

Umcka CC Cherry Syrup:  Keep out of reach of children. Soothing Hot Drink-Lemon Packet:  Keep out of reach of children.

Section 50566-9 (50566-9)

Umcka CC Cherry Syrup: 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. Soothing Hot Drink-Lemon Packet: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 Cherry Syrup: Ask a doctor before use if you have a persistent or chronic cough that lasts, is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema or is accompanied by excessive phlegm (mucus). Soothing Hot Drink-Lemon Packet:  Ask a doctor before use if you have a persistent or chronic cough that lasts, is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema or is accompanied by excessive phlegm (mucus).

Section 51727-6 (51727-6)

Umcka CC Cherry Syrup: aronia juice, citric acid, ethyl alcohol, fructose, glycerin, maltodextrin, natural flavors, potassium sorbate, purified water Soothing Hot Drink-Lemon Packet:citric acid, maltodextrin, natural flavor, silica, 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 Cherry Syrup:  If pregnant or breast-feeding, ask a healthcare professional before use. Soothing Hot Drink-Lemon Packet: If pregnant or breast-feeding, ask a healthcare professional before use.

Section 55105-1 (55105-1)

Umcka CC Cherry Syrup: Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irritations: congestion, cough, hoarseness, sore throat. Soothing Hot Drink-Lemon Packet: Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irritations: congestion, cough, headache, hoarseness, sore throat.

Section 55106-9 (55106-9)

Umcka CC Cherry Syrup: Pelargonium sidoides 1X Soothing Hot Drink-Lemon Packet: Pelargonium sidoides 1X


Raw Label Data

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