Halls Ice Peppermint: Package Insert and Label Information

HALLS ICE PEPPERMINT- 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 8.2 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 1 drop slowly in the mouth. Repeat every 2 hours as needed.
  • children under 5 years: ask a doctor

Other information

  • 10 calories per drop
  • Contains: SOY.

Inactive ingredients

<eucalyptus oil, FDC blue 1, flavors, glucose syrup, 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 12546-111-30 Halls Ice Peppermint 30 ct bag>

MM1MM1
HALLS ICE PEPPERMINT
menthol lozenge
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:12546-111
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Menthol (Menthol) Menthol 8.2 mg
Inactive Ingredients
Ingredient Name Strength
EUCALYPTUS OIL
FD&C BLUE NO. 1
LECITHIN, SOYBEAN
SUCROSE
WATER
Product Characteristics
Color blue (light blue) Score no score
Shape OVAL Size 21mm
Flavor PEPPERMINT (Ice Peppermint) Imprint Code H
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:12546-111-30 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 10/13/2019
Labeler — Mondelez Global LLC (050964956)

Revised: 10/2019 Mondelez Global LLC

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