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Product NDC Code | 54473-132 | ||||
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Drug Name | Counteract cough drops honey lemon |
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Type | Brand | ||||
Active Ingredients |
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Route | ORAL | ||||
Dosage Form | LOZENGE | ||||
RxCUI drug identifier | 253015, 1112209 |
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Application Number | M012 | ||||
Labeler Name | Melaleuca, Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each drop) Menthol 7 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 adults and children 5 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 5 years: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients sucrose, corn syrup, honey, ascorbic acid, sodium ascorbate, beta-carotene, lemon oil, T40-C3 Melaleuca Oil, soybean oil
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 associated with a cold or inhaled irritants occasional minor irritation, pain, sore mouth, 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.CounterAct Cough Drops Honey Lemon Menthol ASCORBIC ACID .BETA.-CAROTENE CORN SYRUP HONEY LEMON OIL SODIUM ASCORBATE SUCROSE TEA TREE OIL MENTHOL MENTHOL Honey Lemon Bright Yellow Drop 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.CounterAct Lemon Cough Drops back.jpg CounterAct Lemon Cough Drops front.jpg
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.
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.Do not use, unless directed by a doctor for more than 7 days if sore mouth symptoms do not improve in 7 days if irritation, pain, or redness persists or worsens if swelling, rash, or fever develops for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema, or where cough is accompanied by excessive phlegm (mucus)
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use
Storage and handling
Information about safe storage and handling of the drug product.Other information 15 calories per lozenge store at room temperature protect from moisture and heat
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 Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by physician. A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a doctor.
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