Halls Kids Honey Apple: Package Insert and Label Information

HALLS KIDS HONEY APPLE- 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 pop) Menthol 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 by fever, headache, rash, swelling, 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 1 pop slowly in the mouth. Repeat every 2 hours as needed.
• children under 5 years: ask a doctor

Other information

• 25 calories per pop

Inactive ingredients

<flavors, glucose syrup, honey, sucrose, 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 12546-350-10 Halls Kids Honey Apple Bag 10 ct>

HALLS KIDS HONEY APPLE menthol lozenge

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:12546-350 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (MENTHOL) MENTHOL 5 mg

Inactive Ingredients Ingredient Name Strength SUCROSE HONEY WATER

Product Characteristics Color yellow (pale yellow) Score no score Shape ROUND Size 20mm Flavor HONEY (Honey Apple) Imprint Code H Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:12546-350-10 10 Lozenge in 1 BAG None 2 NDC:12546-350-11 10 Lozenge in 1 CARTON None 3 NDC:12546-350-01 800 Lozenge in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/30/2020

Labeler — Mondelez Global LLC (050964956)

Establishment
Name	Address	ID/FEI	Operations
BestCo Inc.		002149136	manufacture (12546-350)

Establishment
Name	Address	ID/FEI	Operations
Consumer Packaging Group Inc		612465950	repack (12546-350)

Revised: 03/2020 Mondelez Global LLC