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Thoracol - Medication Information

Product NDC Code 50332-0146
Drug Name

Thoracol

Type Brand
Active Ingredients
Menthol 9 mg/1
Route ORAL
Dosage Form LOZENGE
RxCUI drug identifier 2569961
Application Number part341
Labeler Name HART Health
Packages
Package NDC Code Description
50332-0146-4 50 packet in 1 box (50332-0146-4) / 1 lozenge in 1 packet
50332-0146-7 125 packet in 1 box (50332-0146-7) / 1 lozenge in 1 packet
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each lozenge) Menthol 9 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 Do not take more than directed Adults and children 12 years of age and over: allow one lozenge to dissolve slowly in mouth may be repeated every 2 hours as needed or as directed by a doctor Children under 12 years of age: ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients beta carotene (color), corn syrup, eucalyptus oil, honey, natural & artificial flavors, soy lecithin, 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 sore throat and cough occurring with a cold

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.
THORACOL Honey Lemon Cough Drops MENTHOL MENTHOL BETA CAROTENE CORN SYRUP EUCALYPTUS OIL HONEY LECITHIN, SOYBEAN SUCROSE WATER

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.
Thoracol.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 a doctor before use if you have a cough acccompanied by excessive phlegm (mucus) a persistent or chronic cough such as occurs with smoking, asthma, or emphysema

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. In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other information Contains: SOY 12 calories per drop store at 59° to 86°F (15°-30°C) in a dry place avoid excessive heat and humidity

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 ask a doctor if: sore mouth does improve in 7 days irritation, pain or redness persists or worsens cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache These could be signs of a serious condition

Pregnancy or breast feeding

Pregnancy or Breast feeding
If 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: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor right away

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