HALLS SUGAR FREE MOUNTAIN MENTHOL- menthol lozenge

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredient

(per drop) Menthol 5.8 mg

Purposes

Cough Suppressant, Oral Anesthetic

Uses

temporarily relieves:

• cough due to a cold
• occasional minor irritation or sore throat

Warnings

Sore throat warnings: 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 1 drop slowly in the mouth. Repeat every 2 hours as needed.
• children under 5 years: ask a doctor

Other information

• phenylketonurics: contains phenylalanine 2 mg per drop
• excessive consumption may have a laxative effect
• 5 calories per drop
• contains: SOY.

Inactive ingredients

<acesulfame potassium, aspartame, eucalyptus oil, flavors, isomalt, sodium carboxymethylcellulose, soy lecithin, water>

Questions?

<Call 1-800-524-2854, Monday to Friday2, 9 AM - 6 PM Eastern Time or visit our website atwww.gethalls.com>

OTC Principal Display Panel

INGREDIENTS AND APPEARANCE

HALLS  SUGAR FREE MOUNTAIN MENTHOL
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12546-724
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5.8 mg

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
WATER (UNII: 059QF0KO0R)
ASPARTAME (UNII: Z0H242BBR1)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
EUCALYPTUS OIL (UNII: 2R04ONI662)
ISOMALT (UNII: S870P55O2W)

Product Characteristics
Color	white (CLEAR)	Score	no score
Shape	OVAL	Size	21mm
Flavor	MENTHOL (MOUNTAIN MENTHOL)	Imprint Code	H
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12546-724-01	150000 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	04/29/2026
2	NDC: 12546-724-70	70 in 1 BAG; Type 0: Not a Combination Product	04/29/2026
3	NDC: 12546-724-98	225 in 1 JAR; Type 0: Not a Combination Product	04/29/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	04/29/2026

Labeler - Mondelez Global LLC (091849786)

Establishment
Name	Address	ID/FEI	Business Operations
Mondelez Canada Inc.		246791201	manufacture(12546-724)