FDA Label for Ludens Honey Lemon
View Indications, Usage & Precautions
Ludens Honey Lemon Product Label
The following document was submitted to the FDA by the labeler of this product Prestige Brands Holdings, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Drop)
Pectin 2.8 mg
Purpose
Oral demulcent
Uses
for temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.
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
Directions
- adults and children 3 years of age and older: allow one drop to dissolve slowly in mouth
▪ may be repeated as needed or as directed by a doctor - children under 3 years of age: ask a doctor
Other Information
- store at 20°-25°C (68°-77°F) in a dry place
- Contains FD&C yellow no. 5 (tartrazine) as a color additive
Inactive Ingredients
ascorbic acid, citric acid, corn syrup, FD&C yellow no. 5, honey, lemon oil, sodium acetate, sodium chloride, sucrose, water
Questions?
1-866-583-3677 Ludens.com
Principal Display Panel
Luden’s ®
Honey Lemon
Pectin lozenge/ oral demulcent
25 Throat Drops
Luden’s ®
Honey Lemon
Pectin lozenge/ oral demulcent
90 Throat Drops
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