HALLS NATURALS HONEY LEMON CHAMOMILE- menthol lozenge

Halls Naturals by

Drug Labeling and Warnings

Halls Naturals by is a Otc medication manufactured, distributed, or labeled by Mondelez Global LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

<(in each drop) Menthol 2.5 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, 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

• 15 calories per drop

Inactive ingredients

<citric acid, flavors, ginger, glucose syrup, honey, lemon grass, sage, soy lecithin, sucrose, tea extract, water, white thyme>

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

INGREDIENTS AND APPEARANCE

HALLS NATURALS  HONEY LEMON CHAMOMILE
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12546-224
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.5 mg

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GINGER (UNII: C5529G5JPQ)
HONEY (UNII: Y9H1V576FH)
SAGE (UNII: 065C5D077J)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12546-224-25	25 in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/07/2013

Labeler - Mondelez Global LLC (050964956)