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| Product NDC Code | 72628-107 | ||||
|---|---|---|---|---|---|
| Drug Name | Natural herbal cough drops |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | PASTILLE | ||||
| RxCUI drug identifier | 637119 | ||||
| Application Number | M012 | ||||
| Labeler Name | BOSTON NUTRACEUTICAL PRODUCTION, S.L | ||||
| Packages |
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Overdosage of Natural Herbal 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 in each drop Purposes Menthol 4.8 mg Cough Suppressant Oral Anesthetic
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: allow 2 drops to dissolve slowly in mouth one at a time. Maybe repeated every two hours 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.corn syrup, sucrose, caramel color, elderflower, honehound, hyssop, lemon balm, liden fiwer, malow, peppermint, sage, thyme, wild thyme, natural flavours Back Label
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.Purposes Temporarily relieves : cough as may occur with a cold occasional minor irritation and sore throat
Purpose
Information about the drug product’s indications for use.Purposes Temporarily relieves : cough as may occur with a cold occasional minor irritation and sore throat
Spl product data elements
Usually a list of ingredients in a drug product.Natural Herbal Cough Drops Menthol HYSSOPUS OFFICINALIS FLOWERING TOP CARAMEL HOREHOUND SUCROSE SAMBUCUS NIGRA FLOWER CORN SYRUP MENTHOL MENTHOL LEMON BALM OIL MALVA SYLVESTRIS LEAF PEPPERMINT TILIA CORDATA FLOWER SAGE THYME WILD THYME and herbal dark P
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.Label Label
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 ephysema. Cough accompanied by excessive pleghm (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 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.Other information Store in a cool and dry place 11 calories per drop
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 an adverse event call: 1 617-848-4560 Monday to Friday: 9:00 am to 4:00 pm ET
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 doctor if cough persist for more than 7 days or tends to recur or is accompanied by fever, rash or persistent headache. These could be signs of a serious conditions sore throat is severe or irritation, pain or redness lasts or worsens. sore mouth does not improve in 7 days
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: is sore throat is severe, persist for more than 2 days, is accompanied or followed by fever headache, rash, swelling, nausea and vomiting maybe serious consult a doctor promptly. If sore mouth symptons do not improve in 7 days, see your dentist or doctor promptly. These symptons 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