HALLS MENTHO-LYPTUS- 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:
- 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:
12546-112-14, 12546-112-30, 12546-112-40, 12546-112-80, 12546-112-89, 12546-112-96

HALLS MENTHO-LYPTUS- 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 5.4 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 by fever,

headache, rash, swelling, 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

<citric acid, eucalyptus oil, FDC blue 1, FDC red 40, flavors, glucose syrup, potassium citrate, soy

lecithin, sucrose, water>

Ques tions

<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 12546-112-30 Halls Mentho-Lyptus 30 ct Bag>

HALLS MENTHO-LYPTUS

menthol lozenge

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:12546 -112

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

5.4 mg

Inactive Ingredients

Ingredient Name

Stre ng th

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

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

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

PO TASSIUM CITRATE (UNII: EE9 0 ONI6 FF)

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

SUCRO SE (UNII: C151H8 M554)

Product Characteristics

Color

blue (LIGHT BLUE WITH BLUE SPECKS)

S core

no sco re

S hap e

OVAL

S iz e

21mm

Flavor

MENTHOL (MENTHO-LYPTUS)

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:12546 -112-30

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

0 4/0 7/20 19

2

NDC:12546 -112-14

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

0 9 /0 1/20 20

3

NDC:12546 -112-40

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

0 4/0 7/20 19

4

NDC:12546 -112-8 0

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

0 4/0 7/20 19

5

NDC:12546 -112-8 9

20 0 in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct

0 4/0 7/20 19

6

NDC:12546 -112-9 6

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

0 4/0 7/20 19

Marketing Information

Mondelez Global LLC

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 4/0 7/20 19

Labeler -

Mondelez Global LLC (050964956)

Revised: 9/2020

Similar products

Search alerts related to this product

View documents history

Share this information