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| Product NDC Code | 68599-0465 | ||||
|---|---|---|---|---|---|
| Drug Name | Menthol |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LOZENGE | ||||
| Application Number | M012 | ||||
| Labeler Name | McKesson | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Menthol 8.6 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 do not us e more than directed Adults and children: (12 years and older) Allow 1 drop to dissolve slowly in the mouth. May be repeated every 2 hours as necessary or as directed by a doctor. Children under 12 years: Do not give to children under 12 years of age.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients corn syrup, D&C yellow # 10, eucalyptus oil, FD&C yellow # 6, honey, lemon oil, sucrose
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 a cold or inhaled irritants ■ occasional minor irritation and sore throat
Purpose
Information about the drug product’s indications for use.Purpose Antitussive (cough suppressant)/oral anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Menthol Cough suppressant EUCALYPTUS OIL LEMON OIL SUCROSE D&C YELLOW NO. 10 HONEY FD&C YELLOW NO. 6 FOOD YELLOW 3 FREE ACID CORN SYRUP MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM Translucent Lemon P
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.NDC# 68599-0465-9 McKesson Cough Drops Assorted Honey Lemon 250 per Jar MFR# 27996L 27996L
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
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 ■ 15 calories per drop ■ store at 59º-86ºF (15º-30ºC) ■ protect from moisture & heat
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-800-777-4908
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.Ask a doctor if you have ■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema ■ cough accompanied by excessive phlegm (mucus)
Stop us e and ask a 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 mouth does not improve in 7 days irritation, pain or redness persists or worsens If 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, nausea, or vomiting, consult a doctor promptly. These symptoms 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