HALLS HONEY LEMON- menthol lozenge

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

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Active ingredient:
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Available from:
Mondelez Global LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
- cough due to a cold - occasional minor irritation or sore throat - 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 persists or worsens
Authorization status:
OTC monograph final
Authorization number:
12546-110-02, 12546-110-03, 12546-110-04, 12546-110-14, 12546-110-16, 12546-110-18, 12546-110-24, 12546-110-30, 12546-110-40, 12546-110-80, 12546-110-96, 12546-110-99

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.

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Drug Facts

Active ingredient

<(per drop) Menthol 7.5 mg>

Purpos es

<Cough suppressant, Oral Anesthetic>

Us es

<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

Enter section text here

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>

Ques tions

<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

<NDC 12546-110-30 Halls Honey Lemon 30ct bag>

HALLS HONEY LEMON

menthol lozenge

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:12546 -110

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

7.5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

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

EUCALYPTUS O IL (UNII: 2R0 4ONI6 6 2)

HO NEY (UNII: Y9 H1V576 FH)

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

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

SUCRO SE (UNII: C151H8 M554)

WATER (UNII: 0 59 QF0 KO0 R)

Product Characteristics

Color

yello w (yello w)

S core

no sco re

S hap e

OVAL

S iz e

21mm

Flavor

HONEY (HONEY LEMON)

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:12546 -

110 -18

18 in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct

0 3/24/20 19

2

NDC:12546 -

110 -30

30 in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct

0 3/24/20 19

3

NDC:12546 -

110 -40

40 in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct

0 3/24/20 19

4

NDC:12546 -

110 -8 0

8 0 in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct

0 3/24/20 19

5

NDC:12546 -

110 -16

16 in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct

0 3/24/20 19

NDC:12546 -

Mondelez Global LLC

6

NDC:12546 -

110 -9 6

9 6 in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct

0 3/24/20 19

7

NDC:12546 -

110 -14

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

0 3/24/20 19

8

NDC:12546 -

110 -9 9

16 0 in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct

0 3/24/20 19

9

NDC:12546 -

110 -0 2

150 0 0 0 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0 : No t a

Co mbinatio n Pro duct

12/0 2/20 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 3/24/20 19

Labeler -

Mondelez Global LLC (050964956)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Express Packaging o f Ohio , Inc.

147558 56 3

re pa c k(12546 -110 )

Revised: 12/2019

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