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| Product NDC Code | 83173-110 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Menthol cough suppressant oral anesthetic cough drops |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | LOZENGE | ||||||
| RxCUI drug identifier | 485287 | ||||||
| Application Number | M012 | ||||||
| Labeler Name | Medical Group Care LLC | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each lozenge) Menthol 5.4 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 2 years and over: dissolve lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor • children under 2 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients citric acid, corn syrup, eucalyptus oil, FD&C blue 1, FD&C red 40, menthol flavor, potassium citrate, soy lecithin, sucralose, sucrose, 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.Uses temporarily relieves: • cough due to a cold • occasional minor irritation, pain, sore mouth, and sore throat
Purpose
Information about the drug product’s indications for use.Purposes Cough suppressant/oral anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.MENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC Cough Drops Menthol MENTHOL, UNSPECIFIED FORM MENTHOL CITRIC ACID MONOHYDRATE CORN SYRUP EUCALYPTUS OIL FD&C BLUE NO. 1 FD&C RED NO. 40 POTASSIUM CITRATE SOYBEAN LECITHIN SUCRALOSE SUCROSE WATER B
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.Packaging Cough Drops
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
RESEALABLE BAG COMPARE TO ACTIVE INGREDIENT OF HALLS ® MENTHOL FLAVOR √ SOOTHING DROPS √ GLUTEN FREE √ DAIRY FREE CLOSE BAG TO MAINTAIN FRESHNESS DISTRIBUTED BY: MEDICAL GROUP CARE, LLC NAPLES, FL 34110 MADE IN CHINA This product is not manufactured or distributed by Intercontinental Great Brands LLC., owner of the registered trademark HALLS ® Contains 12 calories per lozenge [email protected] CHOKING HAZARD: • SMALL PARTS CHOKING HAZARD FOR CHILDREN UNDER 4. • CHILDREN SHOULD ALWAYS BE SEATED AND SUPERVISED WHILE EATING.
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call +1-866-306-9136 You may also report concerns to this phone number Monday to Friday, 9 AM -5 PM Eastern Time or visit our website at www.mgc.us
Storage and handling
Information about safe storage and handling of the drug product.Other information • store at room temperature. • keep away from excessive heat or sunlight • do not use if primary bag seal has been torn or broken. • contains: SOY
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. Ask a doctor before use if you have • a persistent or chronic cough such as occurs with smoking, asthma, or emphysema • cough accompanied by excessive phlegm (mucus) When using this product do not exceed recommended dosage Stop use and ask a doctor if • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition • sore mouth symptoms do not improve in 7 days • irritation, pain, or redness persists or worsens Keep this and all drugs out of the reach of children.
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