FDA Label for Hallssugar Free Extra Sugar Free Extra Strong Menthol
View Indications, Usage & Precautions
Hallssugar Free Extra Sugar Free Extra Strong Menthol Product Label
The following document was submitted to the FDA by the labeler of this product Mondelez Global Llc. 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 Ingredients
<(in each drop) 18 mg>
Purposes
<Oral Anesthetic>
Uses
<temporarily relieves occasional minor irritation and pain associated with
- sore throat
- sore mouth>
Warnings
<Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headached, 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 5 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed.
- children under 5 years: ask a doctor
Other Information
- phenylketonurics: contains phenylalanine 2 mg per drop
- excessive consumption may have a laxative effect
- 5 calories per drop
- contains: soy
Inactive Ingredients
<acesulfame potassium, aspartame, citric acid, eucalyptus oil, FDC blue 1, flavors, isomalt, sodium carboxymethylcellulose, soy lecithin, water>
Questions
<Call 1-800-524-2854, Monday to Friday, 9AM-6PM Eastern Time or visit our website at www.gethalls.com>
Otc Principal Display Panel
<Halls Sugar Free Extra Strong Menthol Flavor 9 drops package US NDC 12546-314-09 and CA NDC 67238-314-09>
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