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| Product NDC Code | 0498-1120 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Cough drop |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | ORAL | ||||||||
| Dosage Form | LOZENGE | ||||||||
| RxCUI drug identifier | 253015 | ||||||||
| Labeler Name | Honeywell Safety Products USA, Inc | ||||||||
| 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 (in each drop) Menthol 7 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 2 years of age and over dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed children under 2 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients eucalyptus oil, FD &C red #40, flavoring, glucose syrup, sucrose, 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.Uses temporarily relieves cough as may occur with a cold or inhaled irritants occasional minor irritation, pain, sore mouth 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.Cough Drop Menthol CORN SYRUP EUCALYPTUS OIL FD&C RED NO. 40 SUCROSE WATER MENTHOL MENTHOL CHERRY RED B North Cough Drop Menthol CORN SYRUP EUCALYPTUS OIL FD&C RED NO. 40 SUCROSE WATER MENTHOL MENTHOL CHERRY RED B North Cough Drop Menthol CORN SYRUP EUCALYPTUS OIL FD&C RED NO. 40 SUCROSE WATER MENTHOL MENTHOL CHERRY RED B
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.Principal Display Panel Cough drops
Cough drops original cough drop original
Honeywell Cough Drop Label Honeywellcoughdrops
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 gluten free 15 calories per cough drop store at room temperature protect from moisture soybean oil used as a processing aid do not use if wrapper is open
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 excessive 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 Enter section text here
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 800-430-5490
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 a doctor if a persistant cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompaniedby fever, rash, or persistant headache. irritation, pain, or redness persist or worsen
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, lasts for more than 2 days, is accompanied or followed by a fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly Ask a doctor before use if you have: persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough accompanied by excessive phlegm (mucus) Stop use and ask a doctor if a persistant cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompaniedby fever, rash, or persistant headache. irritation, pain, or redness persist or worsen If pregnant or breast feeding: ask a health professional before use Keep this and all drugs out of the reach of children Enter section text here
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