Halls Mint Bliss: Package Insert and Label Information

HALLS MINT BLISS- 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

<(per drop) Menthol 4.3 mg>

Purposes

<Cough suppressant, Oral Anesthetic

Uses

<temporarily relieves:

  • cough due to a cold
  • ocassional 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

<citric acid, FDC blue 1, FDC yellow 5 (tartrazine), flavors, glucose syrup, potassium citrate, soy lecithin, surose, 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 12546-318-30 Halls Mint Bliss 30 ct bag>

MMI
(click image for full-size original)

HALLS MINT BLISS
menthol lozenge
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:12546-318
Route of Administration Oral DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 4.3 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
POTASSIUM CITRATE
LECITHIN, SOYBEAN
SUCROSE
Water
Product Characteristics
Color green (green) Score no score
Shape OVAL Size 21mm
Flavor MINT Imprint Code H
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:12546-318-30 30 Lozenge in 1 BAG None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 02/02/2016
Labeler — Mondelez Global LLC (050964956)
Establishment
Name Address ID/FEI Operations
Mondelez Canada Inc 246791201 manufacture (12546-318)

Revised: 05/2016 Mondelez Global LLC

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