Halls

Manufacturer
Mondelez Global LLC
Effective date
2019-07-21
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-02 00:18:00

Label at a glance#

ProductHalls Sugar Free Assorted Mints
Active ingredientMENTHOL
Label structure11 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

<(per drop) (Peppermint-blue) Menthol 9.4 mg (Freshmint-light blue) Menthol 5.2 mg (Spearmint-green) Menthol 5 mg>

Purposes

OTC - PURPOSE SECTION

<Cough suppressant, Oral anesthetic>

Uses

INDICATIONS & USAGE SECTION

<temporarily relieves:

  • cough due to a cold
  • occasiona minor irritation or sore throat>

Warnings

WARNINGS SECTION

<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

OTC - ASK DOCTOR SECTION

  • 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

OTC - STOP USE SECTION

  • cough persists for more than 1 week, tends to 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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • phenylketonurics:  contains phenylalanine 2 mg per drop
  • excessive consumption may have a laxative effect
  • 5 calories per drop
  • Contains: SOY.

Inactive ingredients

INACTIVE INGREDIENT SECTION

<acesulfame potassium, aspartame, beta carotene, eucalyptus oil, FDC blue 1, flavors, isomalt, sodium carboxymethylcellulose, soy lecithin, water>

Questions

OTC - QUESTIONS SECTION

<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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

<NDC 12546-692-25 Halls Assorted Mint 25ct bag>

MM1MM1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
12546-69212546-692-25

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f75a7334-b5c8-3fba-e053-6394a90a0e57af4a7dff-14a7-4f08-bcdd-7e192815a46c2023-03-20WarningsExact identifier
spl set id: af4a7dff-14a7-4f08-bcdd-7e192815a46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.