FDA Label for Kofix Cherry And Blackberry

View Indications, Usage & Precautions

Kofix Cherry And Blackberry Product Label

The following document was submitted to the FDA by the labeler of this product Global Health Solution Llc. 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.

Drug Facts




Active Ingredient (In Each Lozenge)



Menthol 8 mg


Purpose



Cough suppressant / Oral anesthetic


Uses



for the temporary relief of  •  cough occurring with a cold  •  occasional minor irritation, pain, sore mouth, and sore throat


Warnings



Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 5 years of age unless directed by physician

Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is  accompanied by excessive phlegm (mucus)

When using this product do not exceed recommended dosage

Stop use and ask a doctor if
•  cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition
• sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting
• sore mouth symptoms do not improve in 7 days  •  irritation, pain, or redness persists or worsens

If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep this and all drugs out of the reach of children.


Directions



• adults and children 5 years and over: dissolve one lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor
• children under 5 years of age: ask a doctor


Other Information



•  store at a cool and dry place 20°C - 25°C (68°F - 77°F) •  protect from heat, humidity and direct sunlight


Inactive Ingredients



anethole, blackberry flavor, black currant liquid extract, carmine, cherry flavor, citric acid, clove oil, cornstarch, eucalyptus oil, gum arabic, sugar


Questions?



+1-800-550-4741, You may also report serious side effects to this phone number. Monday to Friday, 9 AM - 6 PM EST.


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