HALLS Honey Ginger: Package Insert and Label Information

HALLS HONEY GINGER- 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 2.5 mg>

Purposes

<Cough suppressant, Oral anesthetic>

Uses

<temporarily relieves:

• cough due to a cold
• occasional 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

<

• peristent 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 per drop
• Contains : SOY. >

<Inactive ingredients>

<acetic acid, beta carotene, flavors, glucose syrup, honey, soy lecithin, sucrose, water>

Questions

<Call 1-800-524-2854 , Monday to Friday, 9 am to 6 pm eastern time or visit our website at www.gethalls.com>

OTC Principal Display Panel

<NDC 12546-340-30 Halls Honey Ginger 30 ct bag>

HALLS HONEY GINGER menthol lozenge

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:12546-340 Route of Administration Oral DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (MENTHOL) MENTHOL 2.5 mg

Inactive Ingredients Ingredient Name Strength ACETIC ACID .BETA.-CAROTENE HONEY LECITHIN, SOYBEAN SUCROSE WATER

Product Characteristics Color yellow (Pale Yellow) Score no score Shape OVAL Size 21mm Flavor HONEY (Honey Ginger) Imprint Code H Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:12546-340-30 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 07/01/2019

Labeler — Mondelez Global LLC (050964956)

Establishment
Name	Address	ID/FEI	Operations
Mondelez Canada Inc		246791201	manufacture (12546-340)

Revised: 07/2019 Mondelez Global LLC