FDA Label for Cold Relief Zero Sugar Grape

View Indications, Usage & Precautions

Cold Relief Zero Sugar Grape 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


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.


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