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| Product NDC Code | 83002-002 | ||||
|---|---|---|---|---|---|
| Drug Name | Freegells cough drops menthol cherry 80ct |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LOZENGE | ||||
| RxCUI drug identifier | 476973 | ||||
| Application Number | part341 | ||||
| Labeler Name | R.L. ALBERT & SON, INC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Menthol 5.8 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Adults and children 5 years and over dissolve 1 lozenges slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor children under 5 years , ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Corn syrup, eucalyptus oil, FD&C red no.40, natural & artificial flavors, soy lecithin, sucrose and water.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use Temporarily relieves: cough as may occur with a cold occasional minor irritation and sore throat
Purpose
Information about the drug product’s indications for use.Purpose Cough Suppressant / Oral anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Freegells Cough Drops Menthol Cherry 80ct MENTHOL SUCROSE CORN SYRUP EUCALYPTOL LECITHIN, SOYBEAN FD&C RED NO. 40 MENTHOL MENTHOL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Product label image description image description
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Other information 11 calories per drop do not use if bag is torn or open Contains : Soy
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warning Sore throat warning : if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. if sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptoms may be serious. Ask a doctor before use if you have : persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough accompanined by excessive phlegm (mucus) stop use and ask doctor if cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. sore throat is severe, or irritation, pain or redness lasts or worsens sore mouth does not improve in 7 days If pregnant or breast-feeding , ask a health professional before use.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API