Active Ingredient
Pelargonium sidoides 1X
Cold Relief Kids Fastactives Cherry Powder
FDA Label NDC 53499-2166
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 Cold Relief Kids Fastactives Cherry (NDC 53499-2166). 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 active ingredient, inactive ingredients, dosage & administration, indications & usage, purpose, warning, ask doctor, stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredients
Citric Acid
Malic Acid
Maltodextrin
Natural Flavor
Silica
Xylitol
Dosage & Administration
Tear packet open, pour contents into mouth and swallow.
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 contents of 1 packet three times daily
Children 6-12 years of age: take contents of 1 packet two times daily
Children under 6 years of age: consult a doctor
Indications & Usage
Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chest congestion, nasal congestion, cough, hoarseness, sore throat.
Purpose
Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chest congestion, nasal congestion, cough, hoarseness, sore throat.
Warning
Sore throat warning: if sore throat is severe, persists more than 2 days, is accompanied or followed by a fever, headache, rash, nausea, or vomiting, consult a doctor pomptly.
Ask Doctor
Ask a doctor before use if you have a peristent or chronic cough such as occurs occurs with smoking, asthma, chronic bronchitis, or emphysema, a cough that is accompanied by excessive phlegm (mucus), been taking any medications, an allergy to plant to the Geraniaceae family.
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.
Pregnant Or Breast Feeding
If you are pregnant or breast-feeding, ask a healthcare professional before use.
Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose
In case of overdose, seek medical help or contract a Posion Control Center right away.
* Please review the disclaimer below.
