HONEY LEMON COUGH DROPS- menthol pastille

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

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Active ingredient:
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Available from:
Boston Nutraceutical Production SL
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purposes Cough suppressant/ Oral anesthetic Uses Temporarily relieves: - cough as may occur with cold or inhaled irritants - ocassional minor irritations and sore throat Stop use and consult doctor if - cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. - sore throat is severe, or irritation, pain or redness last or worsens - sore mouth does not improve in 7 days
Authorization status:
OTC monograph final
Authorization number:
72628-103-01

HONEY LEMON COUGH DROPS- menthol pastille

Boston Nutraceutical Production SL

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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Honey Lemon Cough Drops

Sugar Free

150 drops

Active Ingredient in each drop Purposes

Menthol 7.6 mg Cough Suppressant

Oral anesthetic

Purposes

Cough suppressant/

Oral anesthetic

Uses Temporarily relieves:

cough as may occur with cold or inhaled irritants

ocassional minor irritations and 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, swealing, nausea, or vomiting, consult a doctor promptly. If sore mouth

symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptons 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 excessvie phlegm (mucus)

Stop use and consult doctor if

cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent

headache. These could be signs of a serious condition.

sore throat is severe, or irritation, pain or redness last or worsens

sore mouth does not improve in 7 days

If pregnant or breast-feeding, ask a health professional before use.

Keep this and all drugs out of the reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 5 years and over: allow 1 drop to dissolve slowly in mouth. May be repeated

every two hours as necessary or as directed by a doctor.

Children under 5 years: ask a doctor

Other information

6 calories per drop

May be useful for diabetics on the advise of a doctor

Excessive consumption may cause laxative effect

Citric acid, eucalyptus oil, isomalt, stevia, flavor lemon oil, flavor honey extract, colorant turmeric,

water

Questions or comments call: 617-848-4560

HONEY LEMON COUGH DROPS

menthol pastille

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:726 28 -10 3

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

7.6 mg

Inactive Ingredients

Ingredient Name

Stre ng th

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

LEMO N O IL (UNII: I9 GRO8 24LL)

HO NEY (UNII: Y9 H1V576 FH)

ISO MALT (UNII: S8 70 P55O2W)

WATER (UNII: 0 59 QF0 KO0 R)

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

STEVIA REBAUDIANA WHO LE (UNII: 6 U422Y0 8 O2)

TURMERIC (UNII: 8 56 YO1Z6 4F)

Product Characteristics

Color

ye llo w

S core

sco re with uneven pieces

S hap e

OVAL

S iz e

17mm

Flavor

HONEY, LEMON

Imprint Code

No ne

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:726 28 -10 3-0 1

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

0 3/26 /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 3/26 /20 19

Labeler -

Boston Nutraceutical Production SL (468121064)

Registrant -

Boston Nutraceutical Science SL (466061824)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Bo sto n Nutraceutical Pro ductio n SL

46 8 1210 6 4

manufacture(726 28 -10 3) , label(726 28 -10 3) , pack(726 28 -10 3)

Boston Nutraceutical Production SL

Revised: 3/2019

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