HALLS HONEY CHAMOMILE- menthol lozenge

United States - English - NLM (National Library of Medicine)

Buy It Now

Active ingredient:
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Available from:
Mondelez Global LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
- - persistent or chronic cough such as occurs with smoking, asthma, or emphysema - cough accompanied by excessive phlegm (mucus) - 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 persist or worsens
Authorization status:
OTC monograph final
Authorization number:
12546-339-25

HALLS HONEY CHAMOMILE- 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.

----------

Drug Facts

Active Ingredient

<(per drop) Menthol 2.5 mg>

Purpos es

<Cough Suppressant, Oral Anesthetic>

Us es

<Temporarily relieves:

- cough due to a cold

- occasional minor irritation or sore throat

suppresses cough to help you sleep>

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 persist 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

15 calories per drop

Contains: SOY.

Inactive ingredients

<beta carotene, flavors, glucose syrup, glycerin, honey, soy lecithin, sucrose, titanium dioxide, water>

Ques tions

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

www.gethalls.com>

OTC Principal Display Panel

<NDC 12546-339-25 Halls Honey Chamomile 25ct Bag>

HALLS HONEY CHAMOMILE

menthol lozenge

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:12546 -339

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

2.5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

.BETA.-CARO TENE (UNII: 0 1YAE0 3M7J)

GLYCERIN (UNII: PDC6 A3C0 OX)

HO NEY (UNII: Y9 H1V576 FH)

LECITHIN, SO YBEAN (UNII: 1DI56 QDM6 2)

SUCRO SE (UNII: C151H8 M554)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

WATER (UNII: 0 59 QF0 KO0 R)

Product Characteristics

Color

white

S core

no sco re

S hap e

OVAL

S iz e

22mm

Flavor

HONEY (Ho ney Chamo mile)

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:12546 -339 -25

25 in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct

0 5/0 5/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

0 5/0 5/20 19

Labeler -

Mondelez Global LLC (050964956)

Mondelez Global LLC

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Mo ndelez Canada Inc

246 79 120 1

ma nufa c ture (12546 -339 )

Revised: 5/2019

Similar products

Search alerts related to this product

View documents history

Share this information