HALLSMELON SPLASH MELON SPLASH- menthol lozenge

HallsMelon Splash by

Drug Labeling and Warnings

HallsMelon Splash 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 3.1 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, persist 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 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

• 15 calories per drop
• contains: soy

Inactive Ingredients

<citric acid, eucalyptus oil, FDC blue 1, FDC yellow 5 (tartrazine), flavors, glucose syrup, 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>

Principal Display Panel

<Halls Melon Splash US NDC: 12546-315-09 and CA NDC: 67238-315-09>

INGREDIENTS AND APPEARANCE

HALLSMELON SPLASH   MELON SPLASH
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12546-315
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3.1 mg

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EUCALYPTUS OIL (UNII: 2R04ONI662)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	green (light green)	Score	no score
Shape	SQUARE	Size	21mm
Flavor	FRUIT (Melon Splash)	Imprint Code	H
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12546-315-09	09 in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/04/2014

Labeler - Mondelez Global LLC (050964956)