HALLS CHERRY- menthol lozenge

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredient

(in each drop) Menthol 7 mg 

Purposes

Cough Suppressant, Oral Anesthetic

Uses

• 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

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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

• 15 calories per drop
• Contains:  SOY

Inactive ingredients

eucalyptus oil, FDC blue 2, FDC red 40, flavors, glucose syrup, soy lecithin, sucralose, 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

Enter section text hereNDC: 12546-165-09 Halls Cherry 9 drops package

INGREDIENTS AND APPEARANCE

HALLS  CHERRY
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12546-165
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	7 mg

Inactive Ingredients
Ingredient Name	Strength
Eucalyptus oil (UNII: 2R04ONI662)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)
water (UNII: 059QF0KO0R)

Product Characteristics
Color	red (red)	Score	no score
Shape	SQUARE	Size	21mm
Flavor	CHERRY (Cherry)	Imprint Code	H
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12546-165-09	09 in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/01/2013

Labeler - Mondelēz Global LLC (050964956)

Establishment
Name	Address	ID/FEI	Business Operations
Mondelēz Canada Inc.		246791201	manufacture(12546-165)