Halls Menthol: Package Insert and Label Information

HALLS MENTHOL- menthol lozenge
Mondelēz Group LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient

<(per drop) Menthol 20 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, 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

Keep out of reach of children.

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

• 15 Calories per drop
• Contains: SOY.

Inactive ingredients

<citric acid, eucalyptus oil, FDC blue 1, flavors, glucose syrup, potassium citrate, soy lecithin, sucralose, sucrose, water>

Questions

<Call 1-800-524-2854 , Monday to Friday, 9 AM — 6PM Eastern Time or visit our website at www.gethalls.com>

OTC Principal Display Panel

<NDC 12546-342-09 Halls Extra Strong Menthol Flavor 9ct stick>

HALLS MENTHOL menthol lozenge

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:12546-342 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Menthol (Menthol) Menthol 20 mg

Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE EUCALYPTUS OIL FD&C BLUE NO. 1 POTASSIUM CITRATE LECITHIN, SOYBEAN SUCRALOSE SUCROSE WATER

Product Characteristics Color white (white with blue specks) Score no score Shape SQUARE Size 22mm Flavor MENTHOL (Extra Strong Menthol) Imprint Code H Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:12546-342-09 09 LOZENGE in 1 PACKAGE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 01/29/2020

Labeler — Mondelēz Group LLC (050964956)

Establishment
Name	Address	ID/FEI	Operations
Mondelēz Canada Inc.		246791201	manufacture (12546-342)

Revised: 01/2020 Mondelēz Group LLC