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| Product NDC Code | 73598-1204 | ||||
|---|---|---|---|---|---|
| Drug Name | Cherry cough drops 100ct |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LOZENGE | ||||
| RxCUI drug identifier | 359751 | ||||
| Application Number | M012 | ||||
| Labeler Name | JHK Inc dba American Safety & First Aid | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (In Each Tablet) Menthol 7.6 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 Adults and children 5 years and over: Allow 1 drop to dissolve slowly in mouth; may be repeated every 2 hours as necessary or as directed by doctor. Children under 5 years: Ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Artificial cherry flavor, corn syrup, eucalyptus oil, FD&C Red No. 40 and 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.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.CHERRY COUGH DROPS 50CT MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM CORN SYRUP EUCALYPTUS OIL FD&C RED NO. 40 SUCROSE P CHERRY COUGH DROPS 100CT MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM CORN SYRUP EUCALYPTUS OIL FD&C RED NO. 40 SUCROSE 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.PRINCIPAL DISPLAY PANEL - 50 Lozenge Box Product #1202 Cherry Flavored Cough Drops Active ingredient: Menthol Cough suppressant/Oral anesthetic Relieves coughs and soothes throats Pleasant tasting cherry flavored lozenge Menthol eucalyptus vapors ease congestion 50 Lozenges PRINCIPAL DISPLAY PANEL - 50 Lozenge Box
PRINCIPAL DISPLAY PANEL - 100 Lozenge Box Product #1204 Cherry Flavored Cough Drops Active ingredient: Menthol Cough suppressant/Oral anesthetic Relieves coughs and soothes throats Pleasant tasting cherry flavored lozenge Menthol eucalyptus vapors ease congestion 100 Lozenges PRINCIPAL DISPLAY PANEL - 100 Lozenge Box
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 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 out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-866-651-3660 Monday-Friday 8:00am-5:00pm EST
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 persists for more than 7 days, 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
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 exceed recommended usage
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding , ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information 10 calories per cough drop store at room temperature protect from moisture and heat
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, swelling nausea or vomiting, consult a 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 accompanied by excessive phlegm (mucus) When using this product do not exceed recommended usage Stop use and ask doctor if cough persists for more than 7 days, 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. Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
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