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
Vclear Berry Dissolving Tablets
FDA Label NDC 59800-3656
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Schwabe North America, Inc. for the product Vclear Berry Dissolving Tablets (NDC 59800-3656). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding vclear berry dissolving tablets, inactive ingredient, dosage & administration, indications & usage, otc - purpose, warnings, otc - keep out of reach of children, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
* Please review the disclaimer below.
