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| Product NDC Code | 76162-011 | ||||
|---|---|---|---|---|---|
| Drug Name | Cough drops |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | PASTILLE | ||||
| RxCUI drug identifier | 485287 | ||||
| Application Number | M012 | ||||
| Labeler Name | Topco Associates LLC | ||||
| Packages |
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Overdosage of 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 5.4 mg Cough Suppressant Oral anesthetic Front Panel
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 12 years and over: dissolve 1 drop slowly in mouth. Repeated every 2 hours as needed or as directed by a doctor. Children under 12 years and under do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.glucose syrup, 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 ocassional minor irritation and sore throat
Purpose
Information about the drug product’s indications for use.Uses temporarily relieves: cough as may occur with a cold ocassional minor irritation and sore throat
Spl product data elements
Usually a list of ingredients in a drug product.Cough Drops Menthol SUCROSE CORN SYRUP MENTHOL MENTHOL None Transparent
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.Back Panel
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 a severe throat accompanied by difficulty in breathing or that last more than 2 days a sore throat accompanied by fever, headache, rash, swelling, nausea or vomiting
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.Store in a cool and dry place
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? or to report and adverse event call: 1-800-423-0139
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 a doctor if sore mouth symptons do not improve in 7 days or if irritation, pains or redness persists or worsens.
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: severe or persistence sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 12 years of age.
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