HALLS HONEY- 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

<(in each drop) Menthol 2.7 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

Directions

• < adults and children 5 years and over: dissolve 2 drops (one at a time) slowly in the mouth. Repeat every 2 hours as needed.
• children under 5 years: ask a doctor>

Other information

• <10 calories
• contains: soy>

Inactive ingredients

<FDC Blue 1, FDC Red 40, FDC Yellow 5 (tartrazine), flavors, glucose syrup, honey, 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: 12546-317-30 Halls Honey 30 ct Bag>

INGREDIENTS AND APPEARANCE

HALLS  HONEY
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12546-317
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.7 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
HONEY (UNII: Y9H1V576FH)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12546-317-30	30 in 1 BAG; Type 0: Not a Combination Product	05/01/2015
2	NDC: 12546-317-40	40 in 1 BAG; Type 0: Not a Combination Product	05/01/2015
3	NDC: 12546-317-80	80 in 1 BAG; Type 0: Not a Combination Product	05/01/2015
4	NDC: 12546-317-02	02 in 1 BAG; Type 0: Not a Combination Product	05/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/01/2015

Labeler - Mondelez Global LLC (050964956)

Establishment
Name	Address	ID/FEI	Business Operations
Mondelez Canada Inc		246791201	manufacture(12546-317)