Active ingredient

(in each 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 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

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

Inactive ingredients

acesulfame potassium, aspartame, eucalyptus oil, FDC blue 1, FDC red 40, flavors, isomalt, sodium carboxymethycellulose, soy lecithin, water

Questions

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

OTC Principal Display Panel

Enter section text here OTC Principal Display Panel 25 Bag

NDC

12546-104-25

Halls Sugar Free Black Cherry

25 Drops Bag

HALLS SUGAR FREE BLACK CHERRY
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	12546-104
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (Menthol)	Menthol	5.8 mg

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color	red (dark red)	Score	no score
Shape	OVAL	Size	3mm
Flavor	CHERRY (Black Cherry)	Imprint Code	H
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	12546-104-25	25 LOZENGE In 1 BAG	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/15/2010

Labeler - Cadbury Adams USA LLC (133306352)

Revised: 06/2010Cadbury Adams USA LLC