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| Product NDC Code | 67777-161 | ||||
|---|---|---|---|---|---|
| Drug Name | Lemon glycerin |
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| Type | Brand | ||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SWAB | ||||
| RxCUI drug identifier | 1114098 | ||||
| Application Number | part356 | ||||
| Labeler Name | Dynarex Corporation | ||||
| 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 Glycerin 7.5%
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 of age and older: Tear open the packet and remove the swabstick. Swab around the mouth and discard. Use as needed or as directed by a dentist or doctor. Childern under 12 years of age should be supervised in the use of this product.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Citric Acid, Lemon Flavor, Sodium Benzoate, 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.Use(s) For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat
Purpose
Information about the drug product’s indications for use.Purpose Oral Demulcent.
Spl product data elements
Usually a list of ingredients in a drug product.Lemon Glycerin Glycerin SODIUM BENZOATE CITRIC ACID MONOHYDRATE WATER GLYCERIN GLYCERIN Lemon Flavor
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.Label 1216 Lemon-Glycerin Swabstick 1216 BX MASTER
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use • If you are allergic to any of the ingredients • On children under 2 years of age unless directed by a doctor or dentist
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 If swallowed, or in case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information • Store at room temperature 15º-30ºC (59º-86ºF) • Avoid excessive heat
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-888-DYNAREX Monday - Friday, 9AM - 5PM EST
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 throat is severe, persists for more than 2 days, and is accompanied or followed by fever, headache, rash, nausea, or vomiting • Sore mouth symptoms do not imrpove in 7 days
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 For Oral Use Only. Do not get in eyes. Do not use • If you are allergic to any of the ingredients • On children under 2 years of age unless directed by a doctor or dentist Stop use and ask a doctor if • Sore throat is severe, persists for more than 2 days, and is accompanied or followed by fever, headache, rash, nausea, or vomiting • Sore mouth symptoms do not imrpove in 7 days Keep out of reach of children If swallowed, or in case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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