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| Product NDC Code | 69626-0043 | ||||
|---|---|---|---|---|---|
| Drug Name | Nice menthol cough drops |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LOZENGE | ||||
| RxCUI drug identifier | 311508, 802773 |
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| Application Number | M012 | ||||
| Labeler Name | Leosons Overseas Corp | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient & Purposes Active ingredient (in each lozenge) Menthol 5 mg Active ingredient (in each lozenge) Purposes Menthol 5 mg..... Cough Suppressant / Oral Anesthetic
| Menthol 5 mg..... | Cough Suppressant / Oral Anesthetic |
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 dissolve a lozenge slowly in mouth may be repeated every hour for coughs as needed or as directed by a doctor may be repeated every 2 hours for sore throat do not take more than 10 lozenges per day adults and children 6 years and older 5 mg children under 6 years ask a doctor
| adults and children 6 years and older | 5 mg |
| children under 6 years | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Acesulfame Potassium, Citric Acid, Eucalyptus Oil, Isomalt, Other Natural and Artificial Flavors.
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 suppresses / relieves: coughs due to minor throat and bronchial irritation from a cold or inhaled irritants occasional minor sore throat pain
Purpose
Information about the drug product’s indications for use.Active ingredient (in each lozenge) Purposes Menthol 5 mg..... Cough Suppressant / Oral Anesthetic
| Menthol 5 mg..... | Cough Suppressant / Oral Anesthetic |
Spl product data elements
Usually a list of ingredients in a drug product.NICE Menthol Cough Drops Menthol ACESULFAME POTASSIUM ACESULFAME MENTHOL MENTHOL ANHYDROUS CITRIC ACID ISOMALT EUCALYPTUS OIL N
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.Package Label Nice Menthol 24ct Cough Drops
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.Drug Facts
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 is you have chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much 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 out of reach of children. Keep out of reach of children.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-855-452-9500 or email at [email protected]
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 ask doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, swelling, nausea or vomiting sore mouth symptoms lasts more than 7 days, or irritation, pain or redness continues or worsens
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product do not use more than directed, taking more may have a laxative effect
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 Warnings Ask a doctor before use is you have chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor before use is you have chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus) Stop use and ask doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, swelling, nausea or vomiting sore mouth symptoms lasts more than 7 days, or irritation, pain or redness continues or worsens When using this product do not use more than directed, taking more may have a laxative effect Keep out of reach of children. Keep out of reach of children.
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