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NDC 72628-0106-01 Menthol Cough Drops 5.8 mg/1 Details

Menthol Cough Drops 5.8 mg/1

Menthol 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	72628-0106
Product ID	72628-106_b8f51795-2015-f2da-e053-2a95a90af7de
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	Menthol Cough Drops
Proprietary Name Suffix	n/a
Non-Proprietary Name	Menthol
Product Type	HUMAN OTC DRUG
Dosage Form	PASTILLE
Route	ORAL
Active Ingredient Strength	5.8
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 72628-0106-01 (72628010601)

Pricing Information	N/A
NDC Package Code	72628-106-01
Billing NDC	72628010601
Package	150 PASTILLE in 1 BAG (72628-106-01)
Marketing Start Date	2019-03-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 857365ba-895e-4a63-e053-2991aa0a8b9f Details

SPL UNCLASSIFIED SECTION

Active Ingredient in each drop Purposes

Menthol 5.8 mg

Cough Suppressant

Oral anesthetic

SPL UNCLASSIFIED SECTION

Purposes

Cough suppressant/

Oral anesthetic

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

Isomalt, stevia, water

SPL UNCLASSIFIED SECTION

Questions or comments call: 617-848-4560

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MENTHOL COUGH DROPS

menthol pastille

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72628-106
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5.8 mg

Ingredient Name	Strength
Inactive Ingredients
ISOMALT (UNII: S870P55O2W)
WATER (UNII: 059QF0KO0R)
STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2)

Product Characteristics
Color	blue (Light blue)	Score	score with uneven pieces
Shape	OVAL	Size	17mm
Flavor	MENTHOL	Imprint Code	None
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72628-106-01	150 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(72628-106) , label(72628-106) , pack(72628-106)

Revised: 1/2021

Document Id: b8f51795-2015-f2da-e053-2a95a90af7de

Set id: 857365ba-895e-4a63-e053-2991aa0a8b9f

Version: 2

Effective Time: 20210115

Search by Drug Name or NDC

NDC 72628-0106-01 Menthol Cough Drops 5.8 mg/1 Details

Menthol Cough Drops 5.8 mg/1

Product Information

Package

Package Images

NDC 72628-0106-01 (72628010601)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 857365ba-895e-4a63-e053-2991aa0a8b9f Details

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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