Halls Mint Bliss: Package Insert and Label Information

HALLS MINT BLISS- menthol lozenge
Mondelez Global 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 4.3 mg>

Purposes

<Cough suppressant, Oral Anesthetic

Uses

<temporarily relieves:

• cough due to a cold
• ocassional minor irritation or 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.>

Ask a doctor before use if you have

• <persistent or chronic cough such as occurs with smoking, asthma, or emphysema
• cough accompanied by excessive phlegm (mucus)>

Stop use and ask a doctor if

• <cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
• 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 2 drops (one at a time) slowly in the mouth. Repeat every 2 hours as needed.
• children under 5 years: ask a doctor>

Other information

• <10 calories
• contains: soy.>

Inactive ingredients

<citric acid, FDC blue 1, FDC yellow 5 (tartrazine), flavors, glucose syrup, potassium citrate, soy lecithin, surose, 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

<NDC 12546-318-30 Halls Mint Bliss 30 ct bag>

HALLS MINT BLISS menthol lozenge

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:12546-318 Route of Administration Oral DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (MENTHOL) MENTHOL 4.3 mg

Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 FD&C YELLOW NO. 5 POTASSIUM CITRATE LECITHIN, SOYBEAN SUCROSE Water

Product Characteristics Color green (green) Score no score Shape OVAL Size 21mm Flavor MINT Imprint Code H Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:12546-318-30 30 Lozenge in 1 BAG None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/02/2016

Labeler — Mondelez Global LLC (050964956)

Establishment
Name	Address	ID/FEI	Operations
Mondelez Canada Inc		246791201	manufacture (12546-318)

Revised: 05/2016 Mondelez Global LLC