Active Ingredient
Pelargonium sidoides 1X
Cold Relief Zero Sugar Grape Syrup
FDA Label NDC 53499-6794
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 Zero Sugar Grape (NDC 53499-6794). 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 and administration, indications & usage, purpose, warnings, ask the doctor, stope 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
Ethyl Alcohol
Glycerin
Maltodextrin
Natural Flavor
Potassium Sorbate
Purified Water
Red Cabbage Juice Color
Sorbitol
Dosage And Administration
Directions
For best results, use at first sign of symptoms and continue to use for an additional 48 hours after symptoms cease.
Shake well before each use.
Use only with enclosed dosage cup.
Adults & children 13 years of age and older: Take 1 ½ teaspoon (tsp) (7.5 mL) three times daily.
Children 6-12 years of age: Take 1 teaspoon (5mL) three 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.
Warnings
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 promptly.
Ask The 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 that is accompanied by excessive phlegm (mucus), been taking any medications, an allergy to plants of the Geraniaceae family.
Stope 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, or cough lasts more than 7 days or occurs with rash or persistent headache.
These could be signs of a serious condition.
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.
Overdose
In case of overdose, seeek medical help or contact a Poison Control Center immediatley.
* Please review the disclaimer below.
