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Product NDC Code | 62583-001 | ||||
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Drug Name | Broncolin herbal extracts and honey |
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Type | Brand | ||||
Active Ingredients |
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Route | ORAL | ||||
Dosage Form | LOZENGE | ||||
RxCUI drug identifier | 1250189, 1495175 |
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Application Number | M012 | ||||
Labeler Name | BRONCOLIN, S.A. de C.V. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Menthol 7.5mg
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 6 years and over: dissolve 1 drop slowly in the mouth. May be repeated every hour as needed or as directed by a doctor. •children under 6 years: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Citric Acid, Elderberry flower, Eucalyptus leaf, Eucalyptus oil, Glucose, Honey, Mullein flower, Propolis, Sugar
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 minor and bronchial occurring with a cold or inhaled irritants •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.BRONCOLIN Herbal extracts and Honey Menthol CITRIC ACID ACETATE SAMBUCUS NIGRA FLOWER EUCALYPTUS PIPERITA LEAF EUCALYPTUS OIL DEXTROSE HONEY VERBASCUM DENSIFLORUM FLOWER PROPOLIS WAX SUCROSE MENTHOL MENTHOL Herbs and Honey Lozenge BEE Amber
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.Package Label image description
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 if pregnant or breast feeding ask a Health Professional before using
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 7 days, tends to recur, 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 dosage
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.
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