FDA Label for Vclear Berry Dissolving Tablets

View Indications, Usage & Precautions

Vclear Berry Dissolving Tablets Product Label

The following document was submitted to the FDA by the labeler of this product Schwabe North America, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Vclear Berry Dissolving Tablets



Active Ingredient:

PELARGONIUM SIDOIDES 1X

ACONITUM NAPELLUS 4X

BRYONIA 4X

EUCALYPTUS GLOBULUS 2X

EUPATORIUM PERFOLIATUM 6X

GELSEMIUM SEMPERVIRENS 4X

IPECACUANHA 3X

PHOSPHORUS 6X


Inactive Ingredient



Inactive Ingredients:

ANNATTO, BEET JUICE COLOR, CARAMEL COLOR, LACTOSE MONOHYDRATE, MAGNESIUM STEARATE, MALIC ACID, MALTODEXTRIN, MANNiTOL,

NATURAL FLAVOR, SODIUM CARBOXYMETHYL, SORBITOL, STEARIC ACID, XYLITOL


Dosage & Administration



Dosage and 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 and children 13 years of age and older: take 1 dissolving tablet 3 times daily.
Children 6-12 years of age: take 1 dissolving tablet 2 times daily.
Children under 6 years of age: consult a physician.


Indications & Usage



Indications and Usage:

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


Otc - Purpose



Purpose:

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


Warnings



Warnings: Sore throat warning: Severe or persistent sore throat for more than 2 days or if accompanied by a high fever, headache, nausea, vomiting or rash may be serious.

Consult a physician promptly.

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).

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.


Otc - Keep Out Of Reach Of Children



Keep out of Reach of Children:

Keep out of reach of children.


Otc - Ask Doctor



Ask the Doctor:

Ask a doctor before use if you have: 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).

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.


Otc - Pregnancy Or Breast Feeding



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


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