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| Product NDC Code | 75712-040 | ||||
|---|---|---|---|---|---|
| Drug Name | Menthol drops dollar general severe 45ct |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LOZENGE | ||||
| Application Number | M012 | ||||
| Labeler Name | Dollar General Corporation | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Menthol 20 mg Purpose 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 12 years and over dissolve 1 lozenge slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor. children under 12 years do not use
| adults and children 12 years and over | dissolve 1 lozenge slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor. |
| children under 12 years | do not use |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Corn Syrup; eucalytus oil; FD&C blue no. 1; FD&C red no. 40; Gum Arabic; Maltodextrin; natural flavor; soy lecithin; sucrose and 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 occasional minor irritation and pain due to: sore throat; sore mouth
Purpose
Information about the drug product’s indications for use.Purpose Oral anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Menthol Drops Dollar General Severe 45ct MENTHOL SUCROSE CORN SYRUP EUCALYPTOL FD&C BLUE NO. 1 FD&C RED NO. 40 ACACIA MALTODEXTRIN LECITHIN, SOYBEAN LEVOMENTHOL LEVOMENTHOL F
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.Product label image description
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
Other information 11 calories per drop do not use if bags is torn or open Contains: Soy
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 gelp or contact a Poison Control Center right away
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: ore throat warning: severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 12 years of age. Ask a doctor before use if you have: a severe sore throat accompanied by difficult in breathing or that lasts more than 2 days a sore accompanied by fever, headache, rash, swelling, nausea or vomiting Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness lasts or worsens If pregnant or breast-feeding ask a health professional before use. Keep out of reach of children. In case of overdose, get medical gelp or contact a Poison Control Center 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