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| Product NDC Code | 53499-6864 | ||||||||||||
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| Drug Name | Cough relief aconitum napellus, bryonia alba root, calcium sulfide, spongia officinalis skeleton, roasted , tin, pelargonium sidoides root |
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| Type | Brand | ||||||||||||
| Active Ingredients |
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| Route | ORAL | ||||||||||||
| Dosage Form | SYRUP | ||||||||||||
| Labeler Name | Schwabe North America, Inc. | ||||||||||||
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Overdosage of Cough Relief ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM SULFIDE, SPONGIA OFFICINALIS SKELETON, ROASTED , TIN, PELARGONIUM SIDOIDES ROOT
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 right away.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Pelargonium sidoides 1X Aconitum napellus 3X Bryonia 3X Hepar sulphuris calcareum 6C Stannum metallicum 6C Spongia tosta 3X
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.Doage & Administration Directions For best results, use at first sign of symptoms and c ontinue to use for an additional 48 hours after symptoms cease. Shake well before each use. Use only with enclosed dosage cup. Adults and Children 13 years of age and older: Take 1 ½ teaspoons (tsp) (7.5 mL) three times daily. Children 6 to 12 years of age: Take 1 teaspoon (5 mL) three times daily. Children under 6 years of age: Consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Citric Acid English Ivy Leaf Extract Ethyl Alcohol Glycerin Lactose Monohydrate Maltodextrin Potassium Sorbate Purified Water Sorbitol
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 the common cold and throat/nasal/bronchial irritations: chest congestion, cough, hoarseness, sore throat, nasal congestion. Temporarily relieves cough due to minor bronchial and throat irritations as may occur with a cold.
Purpose
Information about the drug product’s indications for use.Purpose Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chest congestion, cough, hoarseness, sore throat, nasal congestion. Temporarily relieves cough due to minor bronchial and throat irritations as may occur with a cold.
Spl product data elements
Usually a list of ingredients in a drug product.Cough Relief ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM SULFIDE, SPONGIA OFFICINALIS SKELETON, ROASTED , TIN, PELARGONIUM SIDOIDES ROOT Cough Relief PELARGONIUM SIDOIDES ROOT PELARGONIUM SIDOIDES ROOT ACONITUM NAPELLUS ACONITUM NAPELLUS BRYONIA ALBA ROOT BRYONIA ALBA ROOT CALCIUM SULFIDE CALCIUM SULFIDE TIN TIN SPONGIA OFFICINALIS SKELETON, ROASTED SPONGIA OFFICINALIS SKELETON, ROASTED ANHYDROUS CITRIC ACID HEDERA HELIX LEAF ALCOHOL GLYCERIN LACTOSE MONOHYDRATE MALTODEXTRIN WATER SORBITOL POTASSIUM SORBATE
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... LHBN15864.A01-Cough-Relief-Syrup-4-oz.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 such as occurs with smoking, asthma, chronic bronchitis or emphysema, a cough that is accompanied by excessive phlegm (mucus), been taking any medications, an allergy to plants of the Genaniaceae family.
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 a doctor if new symptoms occur, symptoms get worse or last more than 7 days, fever worsens or lasts more than 3 days, cough lasts more than 7 days or occurs with rash or persistent headache. These could be a sign 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: if sore throat is severe, persists more than 2 days, is accompanied or followed by a fever, headache, rash, nausea, or vomiting, c onsult a doctor 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