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| Product NDC Code | 72628-105 | ||||
|---|---|---|---|---|---|
| Drug Name | Menthol cough drops |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | PASTILLE | ||||
| RxCUI drug identifier | 476973 | ||||
| Application Number | M012 | ||||
| Labeler Name | Boston Nutraceutical Production SL | ||||
| Packages |
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Overdosage of Menthol Cough Drops
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient in each drop Purposes Menthol 5.8 mg Cough Suppressant Oral anesthetic Front label
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: allow 1 drop to dissolve slowly in mouth. May be repeated every two hours as necessary 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.Isomalt, stevia, water Back
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.Uses Temporarily relieves: cough as may occur with cold or inhaled irritants ocassional minor irritations and sore throat
Purpose
Information about the drug product’s indications for use.Purposes Cough suppressant/ Oral anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Menthol Cough Drops Menthol WATER STEVIA REBAUDIANA WHOLE MENTHOL MENTHOL ISOMALT Light blue None
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.Front
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough accompanied by excessvie phlegm (mucus)
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 this and all drugs out of the reach of children.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information 6 calories per drop May be useful for diabetics on the advise of a doctor Excessive consumption may cause laxative effect
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments call: 617-848-4560
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and consult 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 last or worsens sore mouth does not improve in 7 days
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
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.Warnings Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swealing, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptons may be serious.
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