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NDC 72628-0109-01 Honey Lemon Cough Drops 7.6 mg/1 Details

Honey Lemon Cough Drops 7.6 mg/1

Honey Lemon Cough Drops is a ORAL PASTILLE in the HUMAN OTC DRUG category. It is labeled and distributed by Boston Nutraceutical Production SL. The primary component is MENTHOL.

Product Information

NDC	72628-0109
Product ID	72628-109_b8f48a47-6872-f7ed-e053-2995a90a16f3
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Honey Lemon Cough Drops
Proprietary Name Suffix	n/a
Non-Proprietary Name	Menthol
Product Type	HUMAN OTC DRUG
Dosage Form	PASTILLE
Route	ORAL
Active Ingredient Strength	7.6
Active Ingredient Units	mg/1
Substance Name	MENTHOL
Labeler Name	Boston Nutraceutical Production SL
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 72628-0109-01 (72628010901)

Pricing Information	N/A
NDC Package Code	72628-109-01
Billing NDC	72628010901
Package	25 PASTILLE in 1 BAG (72628-109-01)
Marketing Start Date	2019-03-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b8f48a47-6871-f7ed-e053-2995a90a16f3 Details

SPL UNCLASSIFIED SECTION

Active Ingredient in each drop Purposes

Menthol 7.6 mg Cough Suppressant

Oral anesthetic

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Purposes

Cough suppressant/

Oral anesthetic

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Uses Temporarily relieves:

cough as may occur with cold or inhaled irritants
ocassional minor irritations and sore throat

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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)

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

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

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

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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

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Other information

6 calories per drop
May be useful for diabetics on the advise of a doctor
Excessive consumption may cause laxative effect

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Questions or comments call: 617-848-4560

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HONEY LEMON COUGH DROPS

menthol pastille

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72628-109
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	7.6 mg

Ingredient Name	Strength
Inactive Ingredients
EUCALYPTUS OIL (UNII: 2R04ONI662)
LEMON OIL (UNII: I9GRO824LL)
HONEY (UNII: Y9H1V576FH)
ISOMALT (UNII: S870P55O2W)
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2)
TURMERIC (UNII: 856YO1Z64F)

Product Characteristics
Color	yellow	Score	score with uneven pieces
Shape	OVAL	Size	17mm
Flavor	HONEY, LEMON	Imprint Code	None
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72628-109-01	25 in 1 BAG; Type 0: Not a Combination Product	03/26/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	03/26/2019

Labeler - Boston Nutraceutical Production SL (468121064)

Registrant - Boston Nutraceutical Science SL (466061824)

Name	Address	ID/FEI	Business Operations
Establishment
Boston Nutraceutical Production SL		468121064	manufacture(72628-109) , label(72628-109) , pack(72628-109)

Revised: 1/2021

Document Id: b8f48a47-6872-f7ed-e053-2995a90a16f3

Set id: b8f48a47-6871-f7ed-e053-2995a90a16f3

Version: 1

Effective Time: 20210115

Search by Drug Name or NDC

NDC 72628-0109-01 Honey Lemon Cough Drops 7.6 mg/1 Details

Honey Lemon Cough Drops 7.6 mg/1

Product Information

Package

Package Images

NDC 72628-0109-01 (72628010901)

Contents

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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