HALLS BLUEBERRY MINT- menthol lozenge

HALLS by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient (per drop)

Menthol 2.5mg

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:

• 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 per drop
• Contains: SOY.

Inactive ingredients

citric acid, eucalyptus oil, FD&C blue 2, FD&C red 40, flavors, glucose syrup, malic acid, potassium citrate, soy lecithin, sucrose, water

Questions?

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HALLS  BLUEBERRY MINT
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12546-117
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.5 mg

Inactive Ingredients
Ingredient Name	Strength
SUCRALOSE (UNII: 96K6UQ3ZD4)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
CORN SYRUP (UNII: 9G5L16BK6N)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
MALIC ACID (UNII: 817L1N4CKP)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
SUCROSE (UNII: C151H8M554)
EUCALYPTUS OIL (UNII: 2R04ONI662)
FD&C RED NO. 40 (UNII: WZB9127XOA)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	21mm
Flavor	BLUEBERRY	Imprint Code	H
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12546-117-80	80 in 1 BAG; Type 0: Not a Combination Product	09/24/2024
2	NDC: 12546-117-30	30 in 1 BAG; Type 0: Not a Combination Product	09/24/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	09/24/2024

Labeler - Mondelez Global LLC (091849786)

Establishment
Name	Address	ID/FEI	Business Operations
Mondelez Canada Inc.		246791201	manufacture(12546-117)