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| Product NDC Code | 80404-501 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Cough drops |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | ORAL | ||||||||||
| Dosage Form | TABLET, ORALLY DISINTEGRATING | ||||||||||
| RxCUI drug identifier | 485287 | ||||||||||
| Application Number | M012 | ||||||||||
| Labeler Name | Xinsanyang Pharmaceutical (Xiamen) Co., Ltd. | ||||||||||
| 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.Menthol
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.adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeatevery 2 hours as needed. children under 5 years: ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.EUCALYPTUS OIL FD&C BLUE NO. 1 FD&C RED NO. 40 POTASSIUM CITRATE SOY LECITHIN SUCRALOSE SUCROSE GLUCOSE SYRUP CITRIC ACID 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.temporarily relieves: cough due to cold, occasional minor irritation or sore throat
Purpose
Information about the drug product’s indications for use.cough suppressant, oral anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Cough Drops MENTHOL WATER CITRIC ACID MONOHYDRATE MENTHOL MENTHOL EUCALYPTUS OIL FD&C BLUE NO. 1 CORN SYRUP POTASSIUM CITRATE LECITHIN, SOYBEAN FD&C RED NO. 40 SUCRALOSE SUCROSE
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.label0
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.label
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.Cough Drops
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional 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). Stop use and ask a doctor if: cough persists for more than 1 week, tends to recur, or is accompained 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.
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.
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: cough persists for more than 1 week, tends to recur, or is accompained 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.
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.adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeatevery 2 hours as needed. children under 5 years: ask a doctor.
Storage and handling
Information about safe storage and handling of the drug product.Dry, avoid sunlight
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.Sore throat warning: lf sore throat is severe, persists for more than 2 days, isaccompanied or follow headache, rash, swelling, nausea, or vomiting, consult a doctorprompfly. These 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