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Product NDC Code | 42961-233 | ||||||
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Drug Name | Xpect honey lemon cough drops |
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Type | Brand | ||||||
Active Ingredients |
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Route | ORAL | ||||||
Dosage Form | LOZENGE | ||||||
RxCUI drug identifier | 2569961 | ||||||
Application Number | part341 | ||||||
Labeler Name | Cintas Corporation | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each drop) Menthol 9 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 take more than directed adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed. children under 5 years: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients beta carotene (color), corn syrup, eucalyptus oil, honey, natural & artificial flavors, soy lecithin, 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 due to a cold occasional minor irritation or 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.Xpect Honey Lemon Cough Drops Honey Lemon Cough Drops MENTHOL MENTHOL BETA CAROTENE CORN SYRUP EUCALYPTUS OIL HONEY LECITHIN, SOYBEAN SUCROSE WATER
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 - 42961-233-02 HONEY LEMON COUGH DROP Menthol Cough suppressant/oral anesthetic Soothes sore throat Temporarily relieves cough Contains a menthol cough suppressant and oral anesthetic Xpect® First aid 50 Individually Wrapped Drops 50Box
Principal Display Panel - 42961-233-03 HONEY LEMON COUGH DROP Menthol Cough suppressant/oral anesthetic Soothes sore throat Temporarily relieves cough Contains a menthol cough suppressant and oral anesthetic Xpect® First aid 100 Individually Wrapped Drops 100Box
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information 12 calories per drop Contains: SOY
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? 1-877-973-2811 Monday - Friday 8:00 am - 5:00 pm
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 accompanies 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
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 persistent sore throat or sore throat accompanied by high fever, headache, rash, swelling, nausea, or vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days unless directed by a doctor 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 accompanies 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.
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