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| Product NDC Code | 52183-259 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Ludens honey licorice throat drops |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | LOZENGE | ||||||
| RxCUI drug identifier | 616344, 637115, 637116, 753520, 1044433, 1146963 |
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| Application Number | part356 | ||||||
| Labeler Name | Prestige Brands Holdings, Inc. | ||||||
| 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.A ctive ingredient (in each drop) Menthol 2.5 mg
A ctive ingredient (in each drop) Menthol 1.0 mg
A ctive ingredient (in each drop) Menthol 1.6 mg
A ctive ingredient (in each drop) Menthol 1.0 mg
Active ingredient (in each drop) Menthol 1.6 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 3 years of age and older: allow drop to dissolve slowly in mouth. Repeat as necessary every 2 hours, or as directed by doctor. children under 3 years of age: ask a doctor
Directions adults and children 3 years of age and older: allow 2 drops to dissolve slowly in mouth. Repeat as necessary every 2 hours, or as directed by a doctor. children under 3 years of age: ask a doctor
Directions A dults and children 3 years of age and older: allow 1 drop at a time to dissolve slowly in mouth. Repeat as necessary every 2 hours, or as directed by a doctor. C hildren under 3 years of age: ask a doctor
Directions adults and children 3 years of age and older: allow 2 drops to dissolve slowly in mouth. Repeat as necessary every 2 hours, or as directed by a doctor. children under 3 years of age: ask a doctor
Directions A dults and children 3 years of age and older: 2 drops. allow 1 drop at a time to dissolve slowly in mouth. Repeat as necessary every 2 hours, or as directed by a doctor. C hildren under 3 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Caramel Color, Corn Syrup, Flavors, Sodium Acetate, Soybean Oil used as a processing aid, Sucrose, Water
Inactive ingredients Caramel Color, Corn Syrup, Flavors, Glycerin, Honey, Sodium Acetate, Soybean Oil used as a processing aid, Sucrose, Water
Inactive ingredients caramel color, corn syrup, flavors, glycerin, honey, sodium acetate, soybean oil, sucrose.
Inactive ingredients ascorbic acid, citric acid, corn syrup, FD&C yellow 5, flavors, honey, sodium acetate, sodium chloride, soybean oil, sucrose
Inactive ingredients caramel color, corn syrup, flavors, glycerin, honey, sodium acetate, soybean oil, sucrose.
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, pain, sore mouth, and sore throat
Uses temporarily relieves: occasional minor irritation, pain, sore mouth, and sore throat
Uses for temporary relief of occasional minor irritation, pain, sore mouth, and sore throat
Uses temporarily relieves: occasional minor irritation, pain, sore mouth, and sore throat
Uses for temporary relief of occasional minor irritation, pain, sore mouth, and sore throat
Purpose
Information about the drug product’s indications for use.Purpose Oral anesthetic
Purpose Oral anesthetic
Purpose Oral anesthetic
Purpose Oral anesthetic
Purpose Oral anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Ludens Original Menthol Throat Drops Menthol MENTHOL MENTHOL CORN SYRUP SODIUM ACETATE SOYBEAN OIL SUCROSE LUDENS Ludens Honey Licorice Throat Drops Menthol MENTHOL MENTHOL CORN SYRUP GLYCERIN HONEY SODIUM ACETATE SOYBEAN OIL SUCROSE WATER LUDENS Ludens Honey Lemon Throat Drops Menthol MENTHOL MENTHOL ASCORBIC ACID CITRIC ACID MONOHYDRATE CORN SYRUP FD&C YELLOW NO. 5 HONEY SODIUM ACETATE SODIUM CHLORIDE SOYBEAN OIL SUCROSE WATER Honey Lemon LUDENS Ludens Honey Licorice Throat Drops Menthol MENTHOL MENTHOL CORN SYRUP SODIUM ACETATE SOYBEAN OIL SUCROSE GLYCERIN HONEY Ludens Honey Lemon Throat Drops Menthol MENTHOL MENTHOL CORN SYRUP SODIUM ACETATE SOYBEAN OIL SUCROSE HONEY ASCORBIC ACID CITRIC ACID MONOHYDRATE FD&C YELLOW NO. 5 SODIUM CHLORIDE
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.PRINCIPAL DISPLAY PANEL L UDEN ’ S ORIGINAL MENTHOL Menthol lozenge Oral Anesthetic 14 Drops LUDEN’S ORIGINAL MENTHOL Menthol lozenge Oral Anesthetic 14 Drops
Principal Display Panel L UDEN ’ S HONEY LICORICE Menthol lozenge/ Oral Anesthetic 20 Drops LUDEN’S HONEY LICORICE Menthol lozenge/Oral Anesthetic 20 Drops
Principal Display Panel L UDEN ’ S HONEY LICORICE Menthol lozenge Oral Anesthetic 30 Drops LUDEN’S HONEY LICORICE Menthol lozenge Oral Anesthetic 30 Drops
Principal Display Panel L UDEN ’ S HONEY LEMON Menthol lozenge Oral Anesthetic 14 Drops LUDEN’S HONEY LEMON Menthol lozenge Oral Anesthetic 14 Drops
Principal Display Panel L UDEN ’ S HONEY LEMON Menthol lozenge Oral Anesthetic 30 Drops LUDEN’S HONEY LEMON Menthol lozenge Oral Anesthetic 30 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.Luden’s Original Menthol Throat Drops Drug Facts
Other information store at 20-25ºC (68-77ºF) in a dry place Do not use if clear outer wrap is opened or missing.
Other information store at 20-25ºC (68-77ºF) in a dry place do not use if clear outer wrap is opened or missing.
Other information store at 20-25ºC (68-77ºF) in a dry place
Other information store at 20-25ºC (68-77ºF) in a dry place do not use if clear outer wrap is opened or missing. contains FD&C yellow no. 5 (tartrazine) as a color additive
Other information store at 20-25ºC (68-77ºF) in a dry place contains FD&C yellow no. 5 (tartrazine) as a color additive
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
Keep out of reach of children
Keep out of reach of children
Keep out of reach of children
Keep out of 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 1-866-583-3677 Luden’s Honey Licorice Throat Drops Drug Facts
Questions or comments? call 1-866-583-3677 Luden’s Honey Licorice Throat Drops Drug Facts
Questions ? 1-866-583-3677 Ludens.com Luden’s Honey Lemon Throat Drops Drug Facts
Questions? 1-866-583-3677 Ludens.com Luden’s Honey Lemon Throat Drops Drug Facts
Questions ? 1-866-583-3677 Ludens.com
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 not improve in 7 days irritation, pain or redness lasts or worsens.
Stop use and ask a doctor if sore mouth does not improve in 7 days irritation, pain or redness lasts or worsens
Stop use and ask a doctor if sore mouth does not improve in 7 days irritation, pain or redness persists or worsens.
Stop use and ask a doctor if sore mouth does not improve in 7 days irritation, pain or redness lasts or worsens
Stop use and ask a doctor if sore mouth does not improve in 7 days irritation, pain or redness persists or worsens.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a doctor before use.
If pregnant or breast-feeding, ask a doctor before use.
If pregnant or breast-feeding, ask a health professional before use.
If pregnant or breast-feeding, ask a doctor before use.
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, swelling, nausea or vomiting, consult a doctor promptly. These may be serious. Stop use and ask a doctor if : sore mouth does not improve in 7 days irritation, pain or redness lasts or worsens. If pregnant or breast-feeding, ask a doctor before use. Keep out of reach of children
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. These may be serious. Stop use and ask a doctor if sore mouth does not improve in 7 days irritation, pain or redness lasts or worsens If pregnant or breast-feeding, ask a doctor before use. Keep out of reach of children
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. These may be serious. Stop use and ask a doctor if sore mouth does not improve in 7 days irritation, pain or redness persists or worsens. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children
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. These may be serious. Stop use and ask a doctor if sore mouth does not improve in 7 days irritation, pain or redness lasts or worsens If pregnant or breast-feeding, ask a doctor before use. Keep out of reach of children
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. These may be serious. Stop use and ask a doctor if sore mouth does not improve in 7 days irritation, pain or redness persists or worsens. If pregnant or breast-feeding, ask a health professional before use. Keep out of 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