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Product NDC Code | 53499-5272 | ||||||
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Drug Name | Umcka menthol |
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Type | Brand | ||||||
Active Ingredients |
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Route | ORAL | ||||||
Dosage Form | SYRUP | ||||||
Labeler Name | Schwabe North America, Inc | ||||||
Packages |
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Overdosage of Umcka Menthol
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.Overdose In case of overdose, seek medical help or contact a Poison Control Center immediately.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Pelargonium sidoides 1X
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.Dosage & Administration Directions For best results, use at first sign of symptoms. Continue to use for an additional 48 hours after symptoms cease. Use only with enclosed dosage cup. Adults & children 12 years of age and older: Take 1 ½ teaspoon (tsp) (7.5 mL) 3 times daily. Children under 12 years of age: Consult a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredient Ethyl Alcohol Fructose Glycerin Maltodextrin Menthol Natural Flavor Purified 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.Indications & Usage Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irritations: congestion, cough, hoarseness, sore throat.
Purpose
Information about the drug product’s indications for use.Purpose Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irritations: congestion, cough, hoarseness, sore throat.
Spl product data elements
Usually a list of ingredients in a drug product.Umcka Menthol Pelargonium sidoides ALCOHOL FRUCTOSE MENTHOL WATER GLYCERIN MALTODEXTRIN PELARGONIUM SIDOIDES ROOT PELARGONIUM SIDOIDES ROOT NATURAL MENTHOL FLAVOR NATURAL SPEARMINT FLAVOR
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.Add image transcription here... 15272_Umcka Menthol Syrup_A01.jpg
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 Doctor Ask a doctor before use if you have a persistent or chronic cough that lasts, is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or is 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. 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 Stop use and ask the doctor if new symptoms occur, symptoms worsen or do not get better within 7 days, fever worsens or lasts more than 3 days, or cough lasts more than 7 days or occurs with rash or persistent headache. These could be signs of a serious condition.
Pregnancy or breast feeding
Pregnancy or Breast feedingPregnancy or Breast Feeding If pregnant or breast-feeding, ask a healthcare 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 persistent sore throat for more than 2 days or if accompanied by a high fever, headache, nausea, vomiting, or rash may be serious. Consult a physician promptly.
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