FDA Label for Cold Flu Relief Berry Chewable
View Indications, Usage & Precautions
Cold Flu Relief Berry Chewable Product Label
The following document was submitted to the FDA by the labeler of this product Schwabe North America, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
PELARGONIUM SIDOIDES 1X
ACONITUM NAPELLUS 4X
EUCALYPTUS GLOBULUS 2X
BRYONIA 4X
EUPATORIUM PERFOLIATUM 6X
GELSEMIUM SEMPERVIRENS 4X
PHOSPHORUS 6X
IPECACUANHA 3X
Inactive Ingredient
ANNATTO SEED EXTRACT COLOR
BEET JUICE COLOR
CARAMEL COLOR
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MALIC ACID
MALTODEXTRIN
MANNITOL
NATURAL FLAVOR
SODIUM CROSCARMELLOSE
SORBITOL
STEARIC ACID
XYLITOL
Indications & Usage
Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations, and temporarily relieves flu symptoms: chills/fever, congestion/stuffy nose, cough, headache, hoarseness, minor aches/pains, sneezing/runny nose, sore throat
Purpose
Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations, and temporarily relieves flu symptoms: chills/fever, congestion/stuffy nose, cough, headache, hoarseness, minor aches/pains, sneezing/runny nose, sore throat
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 chewable tablet 3 times daily.
Children 6-12 years of age: Take 1 chewable tablet 2 times daily.
Children under 6 years of age: Consult a doctor.
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 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 contact a Poison Control Center right away.
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