Halls Mentholyptus: Package Insert and Label Information

HALLS MENTHOLYPTUS- menthol lozenge
Mondelēz 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 6.4 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

  • 15 calories per drop
  • Contains: SOY.

Inactive ingredients

<citric acid, eucalyptus oil, FDC blue 1, FDC red 40, 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>

OTC Principal Display Panel

<NDC 12546-334-09 Halls Mentho-Lyptus Stick 9ct>

MM1
(click image for full-size original)
HALLS MENTHOLYPTUS
menthol lozenge
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:12546-334
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Menthol (Menthol) Menthol 6.4 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
eucalyptus oil
FD&C BLUE NO. 1
FD&C RED NO. 40
POTASSIUM CITRATE
LECITHIN, SOYBEAN
sucrose
water
Product Characteristics
Color white (white with blue specks) Score no score
Shape SQUARE Size 21mm
Flavor MENTHOL (Mentholyptus) Imprint Code H
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:12546-334-09 09 LOZENGE in 1 PACKAGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 04/07/2019
Labeler — Mondelēz Global LLC (050964956)
Establishment
Name Address ID/FEI Operations
Mondelēz Canada Inc. 246791201 manufacture (12546-334)

Revised: 04/2019 Mondelēz Global LLC

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