Cold + Flu Relief Orange Chewables

Cold + Flu Relief Orange Chewables
SPL v4
SPL
SPL Set ID 2983e4bd-065a-4f9f-904f-440336106096
Route
ORAL
Published
Effective Date 2025-08-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pelargonium Sidoides Root (1 [hp_X]) Aconitum Napellus (4 [hp_X]) Bryonia Alba Root (2 [hp_X]) Eucalyptus Globulus Leaf (6 [hp_X]) Eupatorium Perfoliatum Flowering Top (3 [hp_X]) Gelsemium Sempervirens Root Ipecac Phosphorus
Inactive Ingredients
Citric Acid Monohydrate Lactose Monohydrate Magnesium Stearate Malic Acid Maltodextrin Mannitol Sorbitol Stearic Acid Xylitol

Identifiers & Packaging

Pill Appearance
Imprint: UMCKA Shape: round Color: white Size: 16 mm
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2024-06-21

Description

Pelargonium sidoides 1X Aconitum napellus 4X Eucalyptus globulus 2X Bryonia 4X Eupatorium perfoliatum 6X Gelsemium sempervirens 4X Phosphorus 6X Ipecacuanha 3X

Purpose

Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations, and temporarily relieves flu symptoms: chills/fever, chest congestion, nasal congestion, cough, headache, hoarseness, body aches, sneezing/runny nose, sore throat.


Medication Information

Purpose

Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations, and temporarily relieves flu symptoms: chills/fever, chest congestion, nasal congestion, cough, headache, hoarseness, body aches, sneezing/runny nose, sore throat.

Description

Pelargonium sidoides 1X Aconitum napellus 4X Eucalyptus globulus 2X Bryonia 4X Eupatorium perfoliatum 6X Gelsemium sempervirens 4X Phosphorus 6X Ipecacuanha 3X

Section 51945-4

Stop Use

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

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by a fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Ask Doctor

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 accompanied by excessive phlegm (mucus), been taking any medications, an allergy to plants of the Geraniaceae family.

Overdose 

In case of overdoese, seek medical help or contact a Poison Control Center right away. 

Active Ingredients

Pelargonium sidoides 1X

Aconitum napellus 4X

Eucalyptus globulus 2X

Bryonia 4X

Eupatorium perfoliatum 6X

Gelsemium sempervirens 4X

Phosphorus 6X

Ipecacuanha 3X

Indications & Usage

Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations, and temporarily relieves flu symptoms: chills/fever, chest congestion, nasal congestion, cough, headache, hoarseness, body aches, sneezing/runny nose, sore throat. 

Inactive Ingredients

Citric Acid

Lactose Monohydrate

Magnesium Stearate

Malic Acid

Maltodextrin

Mannitol

Natural Flavor

Sorbitol

Stearic Acid

Xylitol

Dosage & Administration

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 & children 13 years of age and older: Take 1 chewable tablet three times daily.

Children 6-12 years of age: Take 1 chewable tablet two times daily.

Children under 6 years of age: Consult a doctor.

Pregnancy Or Breast Feeding

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

Keep Out of Reach of Children

Keep out of reach of children.


Structured Label Content

Section 51945-4 (51945-4)

Purpose

Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations, and temporarily relieves flu symptoms: chills/fever, chest congestion, nasal congestion, cough, headache, hoarseness, body aches, sneezing/runny nose, sore throat.

Stop Use (Stop use)

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

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by a fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Ask Doctor

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 accompanied by excessive phlegm (mucus), been taking any medications, an allergy to plants of the Geraniaceae family.

Overdose 

In case of overdoese, seek medical help or contact a Poison Control Center right away. 

Active Ingredients

Pelargonium sidoides 1X

Aconitum napellus 4X

Eucalyptus globulus 2X

Bryonia 4X

Eupatorium perfoliatum 6X

Gelsemium sempervirens 4X

Phosphorus 6X

Ipecacuanha 3X

Indications & Usage

Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations, and temporarily relieves flu symptoms: chills/fever, chest congestion, nasal congestion, cough, headache, hoarseness, body aches, sneezing/runny nose, sore throat. 

Inactive Ingredients

Citric Acid

Lactose Monohydrate

Magnesium Stearate

Malic Acid

Maltodextrin

Mannitol

Natural Flavor

Sorbitol

Stearic Acid

Xylitol

Dosage & Administration

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 & children 13 years of age and older: Take 1 chewable tablet three times daily.

Children 6-12 years of age: Take 1 chewable tablet two times daily.

Children under 6 years of age: Consult a doctor.

Pregnancy Or Breast Feeding (Pregnancy or Breast Feeding)

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

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

Keep out of reach of children.


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Raw Label Data

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