OTC Medication Information: HallsMelon Splash Melon Splash

HALLSMELON SPLASH MELON SPLASH- menthol lozenge
Mondelez Global LLC

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.

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

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>

MM1
(click image for full-size original)

HALLSMELON SPLASH MELON SPLASH
menthol lozenge
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:12546-315
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 3.1 mg
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
EUCALYPTUS OIL
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
POTASSIUM CITRATE
LECITHIN, SOYBEAN
SUCROSE
WATER
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 Multilevel Packaging
1 NDC:12546-315-09 09 LOZENGE (LOZENGE) in 1 PACKAGE None
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)

Revised: 02/2014 Mondelez Global LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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