Active Ingredients
Pelargonium sidoides 1X
Aconitum napellus 4X
Eucalyptus globulus 2X
Bryonia 4X
Eupatorium perfoliatum 6X
Gelsemium sempervirens 4X
Phosphorus 6X
Ipecacuanha 3X
Cold Flu Relief Berry Syrup
FDA Label NDC 53499-0148
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 Cold Flu Relief Berry (NDC 53499-0148). 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 ingredients, inactive ingredient, dosage & administration, purpose, indications & usage, warnings, 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 Ingredient
Aronia Juice
Citiric Acid
Ethyl Alcohol
Glycerin
Lactose Monohydrate
Maltodextrin
Natural Flavor
Potassium Sorbate
Purified Water
Sorbitol
Dosage & Administration
Directions
For best results, use at the 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 1½ teaspoon (tsp) (7.5 mL) three times daily.
Children 6 to 12 years of age: Take 1 teaspoon (5 mL) three times daily.
Children under 6 years of age: consult a doctor.
Purpose
Temporarily relieves flu symptoms.
Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chills/fever, chest congestion, cough, headache, hoarseness, body aches, sore throat, sneezing/runny nose, nasal congestion.
Indications & Usage
Temporarily relieves flu symptoms.
Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chills/fever, chest congestion, cough, headache, hoarseness, body aches, sore throat, sneezing/runny nose, nasal congestion.
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 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.
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.
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, seek medical help or contact a Poison Control Center right away.
* Please review the disclaimer below.
