HALLS SUGAR FREE CITRUS BLEND- 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 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

Enter section text here

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, beta carotene, eucalyptus oil, flavors, isomalt, sodium carboxymethylcellulose, 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: 12546-613-25 Halls SF Citrus Blend 25ct bag>

INGREDIENTS AND APPEARANCE

HALLS  SUGAR FREE CITRUS BLEND
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12546-613
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
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ASPARTAME (UNII: Z0H242BBR1)
.BETA.-CAROTENE (UNII: 01YAE03M7J)
EUCALYPTUS OIL (UNII: 2R04ONI662)
ISOMALT (UNII: S870P55O2W)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	yellow (light yellow)	Score	no score
Shape	OVAL	Size	21mm
Flavor	CITRUS (CITRUS BLEND)	Imprint Code	H
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12546-613-25	25 in 1 BAG; Type 0: Not a Combination Product	07/14/2019
2	NDC: 12546-613-70	70 in 1 BAG; Type 0: Not a Combination Product	07/14/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/14/2019

Labeler - Mondelez Global LLC (050964956)