HALLS KIDS HONEY APPLE- menthol lozenge

Halls Kids by

Drug Labeling and Warnings

Halls Kids by is a Otc medication manufactured, distributed, or labeled by Mondelez Global LLC, BestCo Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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>

INGREDIENTS AND APPEARANCE

HALLS KIDS  HONEY APPLE
menthol lozenge

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 mg

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)
HONEY (UNII: Y9H1V576FH)
WATER (UNII: 059QF0KO0R)

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	Marketing Start Date	Marketing End Date
1	NDC: 12546-350-10	10 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
2	NDC: 12546-350-11	10 in 1 CARTON; Type 0: Not a Combination Product	03/30/2020
3	NDC: 12546-350-01	800 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	03/30/2020	05/25/2021

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	Business Operations
BestCo Inc.		002149136	manufacture(12546-350)

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