Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameMENTHOL
Labeler / manufacturerPrestige Brands Holdings, Inc.
Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.
Uses described in the label
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
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
Warnings
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
Unclassified section
Luden’s Original Menthol Throat Drops Drug Facts
Active ingredient
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
When to stop use and seek help
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
If 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.
Child safety
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
Other safety information
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
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.