HALLS SUGAR FREE WATERMELON- menthol lozenge

Halls by

Drug Labeling and Warnings

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

Drug Details [pdf]

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, persist 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.

In case of overdose, get medical help or contact a Poison Control Center right away

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

• phenylketonurics: contains phenylalanine 0.5 mg per drop
• excessive consumption may have a laxative effect
• <5 calories per drop
• Contains: SOY.

Inactive ingredients

acesulfame potassium, aspartame, citric acid, eucalyptus oil, FD&C red 40, flavors (includes cinnamon), isomalt, soy lecithin, water

Questions

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

OTC Principal Display Panel

<NDC: 12546-351-24 Halls Sugar Free Watermelon 24ct>

INGREDIENTS AND APPEARANCE

HALLS  SUGAR FREE WATERMELON
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12546-351
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
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ASPARTAME (UNII: Z0H242BBR1)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
WATER (UNII: 059QF0KO0R)
EUCALYPTUS OIL (UNII: 2R04ONI662)
FD&C RED NO. 40 (UNII: WZB9127XOA)
ISOMALT (UNII: S870P55O2W)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	9mm
Flavor	WATERMELON	Imprint Code	H
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12546-351-24	24 in 1 PACKAGE; Type 0: Not a Combination Product	12/13/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/13/2021

Labeler - Mondelez Global LLC (050964956)

Establishment
Name	Address	ID/FEI	Business Operations
MSI Express, Inc		117973852	pack(12546-351)

Establishment
Name	Address	ID/FEI	Business Operations
Mondelez Canada Inc		246791201	manufacture(12546-351)