Halls Honey Lemon: Package Insert and Label Information

HALLS HONEY LEMON- 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 7.5 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

<beta carotene, eucalyptus oil, flavors, glucose syrup, honey, soy lecithin, sucralose, sucrose, water>

Questions

<Call 1-800-524-2854 , Monday to Friday, 9 AM-6PM Eastern Time or visit our website at www.gethalls.com>

OTC Principal Display Panel

Halls Honey lemon 30ct
(click image for full-size original)

HALLS HONEY LEMON
menthol lozenge
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:12546-110
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 7.5 mg
Inactive Ingredients
Ingredient Name Strength
EUCALYPTUS OIL
HONEY
LECITHIN, SOYBEAN
SUCRALOSE
SUCROSE
WATER
.BETA.-CAROTENE
Product Characteristics
Color yellow (yellow) Score no score
Shape OVAL Size 21mm
Flavor HONEY (HONEY LEMON) Imprint Code H
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:12546-110-18 18 LOZENGE in 1 BAG None
2 NDC:12546-110-30 30 LOZENGE in 1 BAG None
3 NDC:12546-110-24 24 LOZENGE in 1 BAG None
4 NDC:12546-110-40 40 LOZENGE in 1 BAG None
5 NDC:12546-110-80 80 LOZENGE in 1 BAG None
6 NDC:12546-110-16 16 LOZENGE in 1 BAG None
7 NDC:12546-110-96 96 LOZENGE in 1 BAG None
8 NDC:12546-110-14 14 LOZENGE in 1 PACKAGE None
9 NDC:12546-110-99 160 LOZENGE in 1 BAG None
10 NDC:12546-110-02 150000 LOZENGE in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK None
11 NDC:12546-110-03 2400 LOZENGE in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK None
12 NDC:12546-110-04 720 LOZENGE in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK None
13 NDC:12546-110-00 250 LOZENGE in 1 JAR None
14 NDC:12546-110-01 140 LOZENGE in 1 BAG None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 03/24/2019
Labeler — Mondelez Global LLC (050964956)
Establishment
Name Address ID/FEI Operations
MSI Express, Inc. 117973852 pack (12546-110)
Establishment
Name Address ID/FEI Operations
Mondelez Canada Inc. 246791201 manufacture (12546-110)

Revised: 09/2022 Mondelez Global LLC

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