HALLS APPLE CIDER- menthol lozenge
Kraft Foods Global, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredient

(in each drop) Menthol 5.7 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

15 calories per drop
contains: soy.

Inactive ingredients

beta carotene, caramel color, FDandC blue 1, FDandC red40, FDandC yellow 5 , flavors, glucose syrup, glycerin, malic acid, partially hydrogentated cottonseed oil, potassium citrate, soy lecithin, 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

NDC 12546-106-20 Halls Warm Ups Apple Cider 20 Drops Bag

HALLS APPLE CIDER
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:12546-106
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (Menthol)	Menthol	5.7 mg

Inactive Ingredients
Ingredient Name	Strength
BETA CAROTENE
CARAMEL
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 5
GLYCERIN
MALIC ACID
POTASSIUM CITRATE
LECITHIN, SOYBEAN
SUCROSE
WATER

Product Characteristics
Color	brown (LIGHT BROWN)	Score	no score
Shape	OVAL	Size	22mm
Flavor	APPLE (APPLE CIDER FLAVOR)	Imprint Code	H
Contains

Packaging
#	Item Code	Package Description
1	NDC:12546-106-20	20 in 1 BAG
2	NDC:12546-106-02	2 in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/01/2011

Labeler - Kraft Foods Global, Inc. (039010590)

Revised: 04/2011

Document Id: 6c5d8739-e0ae-4b1e-a433-d1ce955d087b

Set id: 2bf87c75-c988-4937-92fe-9400e5fab8e2

Version: 2

Effective Time: 20110429

Kraft Foods Global, Inc.