FDA Label for Ludens Honey And Berry

View Indications, Usage & Precautions

Ludens Honey And Berry 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 20-25C (68-77F) in a dry place


Inactive Ingredients



caramel color, citric acid, corn syrup, FD&C blue no. 1, FD&C red no. 40, flavor, honey, sodium acetate, sodium chloride, soybean oil, sucrose, water


Questions?



1-866-583-3677 Ludens.com


Principal Display Panel



Luden’s

Pectin lozenge/ Oral demulcent
Honey & Berry
25 Throat Count


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