Otc - Active Ingredient
Active Ingredient:
PELARGONIUM SIDOIDES 1X
Viraclear Eps 7630 Original Liquid
FDA Label NDC 59800-8001
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 for the product Viraclear Eps 7630 Original (NDC 59800-8001). 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 otc - active ingredient, 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:
Ethyl Alcohol (13%)
Purified Water
Glycerin
Dosage & Administration
Dosage and Administration:
Integrative Therapeutics Brand:
Directions:
For best results, use at first sign of symptoms and continue to use for an additional 48 hours after symptoms cease.
Adults and children 12 years of age and older: Take 1.5 mL 3 times daily.
Children under 12 years of age: Consult a doctor
Indications & Usage
Indications and Usage:
Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations:
congestion, cough, headache, hoarseness, sore throat.
Otc - Purpose
Purpose:
Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations:
congestion, cough, headache, hoarseness, sore throat.
Warnings
Warnings:
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.
Stop use and consult a doctor if new symptoms occur, symptoms get worse or last more than 7 days.
Cough lasts more than 7 days or occurs with rash or persistent headache.
Fever worsens or lasts more than 3 days.
These could be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of Reach of Children:
Keep out of the reach of children. In case of overdose, seek medical hlep or contact a Poison Control Center immediately.
Otc - Ask Doctor
Ask the Doctor:
Consult a doctor before use if you have a persistent or chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema or is accompanied by excessive phlegm(mucus).
Stop use and consult a doctor if new symptoms occur, symptoms get worse or last more than 7 days.
Cough lasts more than 7 days or occurs with rash or persistent headache.
Fever worsens or lasts more than 3 days.
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
Pregnancy or Breast Feeding:
If pregnant or breast-feeding, ask a healthcare professional before use.
Overdosage
Overdose:
In case of overdose, seek medical help or contact a Poison Control Center immediately.
V Clear Eps 7630 Original Formula
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