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NDC 47682-0840-25 Medi-First Honey Lemon Cough Drops 8.6 mg/1 Details

Medi-First Honey Lemon Cough Drops 8.6 mg/1

Medi-First Honey Lemon Cough Drops is a ORAL LOZENGE in the HUMAN OTC DRUG category. It is labeled and distributed by Unifirst First Aid Corporation. The primary component is MENTHOL.

Product Information

NDC	47682-0840
Product ID	47682-840_da454739-60b3-28ae-e053-2a95a90a84ed
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	Medi-First Honey Lemon Cough Drops
Proprietary Name Suffix	n/a
Non-Proprietary Name	Menthol 8.6 mg
Product Type	HUMAN OTC DRUG
Dosage Form	LOZENGE
Route	ORAL
Active Ingredient Strength	8.6
Active Ingredient Units	mg/1
Substance Name	MENTHOL
Labeler Name	Unifirst First Aid Corporation
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 47682-0840-25 (47682084025)

Pricing Information	N/A
NDC Package Code	47682-840-25
Billing NDC	47682084025
Package	125 LOZENGE in 1 BOX (47682-840-25)
Marketing Start Date	2019-03-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 826e1b87-e5a9-8637-e053-2991aa0aded1 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each drop)

Menthol 8.6 mg

Purpose

Antitussive (cough suppressant)/oral anesthetic

Uses

Temporarily relieves

■ cough as may occur with a cold or inhaled irritants

■ occasional minor irritation 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, nausea, or vomiting, consult a doctor promptly. These symptoms 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 7 days, 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

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.

Directions

■ do not use more than directed

Adults and children: (12 years and older)

Allow 1 drop to dissolve slowly in the mouth. May be repeated every 2 hours as necessary or as directed by a doctor.

Children under 12 years:

Do not give to children under 12 years of age.

Other information

■ 15 calories per drop

■ store at 59º-86ºF (15º-30ºC)

■ protect from moisture & heat

Inactive ingredients

corn syrup, eucalyptus oil, D&C yellow #10, FD&C yellow #6, honey, lemon oil, sucrose

Questions or comments?

1-800-634-7680

Medi-First Cough Drop Label

125

drops

Medi-First®

Honey Lemon

Cough Drops

Vapor Action

Pull to Open

Cough Suppressant • Menthol 8.6 mg

Compare active ingredients to:

Halls®

Registered Trademark of Warner-Lambert

Individually Wrapped Cough Drops

Medi-First Plus Honey Lemon Label

125 Drops

Medi-First Plus®

Honey Lemon

Cough Drops

Menthol 8.6 mg

Pull to Open

Cough Suppressant & Anesthetic

with Vapor Action

Compare active ingredients to:

Halls®

Registered Trademark of Warner-Lambert

Individually Wrapped Cough Drops

INGREDIENTS AND APPEARANCE

MEDI-FIRST HONEY LEMON COUGH DROPS

menthol 8.6 mg lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:47682-840
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	8.6 mg

Ingredient Name	Strength
Inactive Ingredients
CORN SYRUP (UNII: 9G5L16BK6N)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
EUCALYPTUS OIL (UNII: 2R04ONI662)
HONEY (UNII: Y9H1V576FH)
LEMON OIL (UNII: I9GRO824LL)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	yellow	Score	no score
Shape	OVAL	Size	22mm
Flavor	HONEY (Lemon)	Imprint Code	P
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:47682-840-25	125 in 1 BOX; Type 0: Not a Combination Product	03/18/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	03/18/2019

MEDI-FIRST PLUS HONEY LEMON COUGH DROPS

menthol 8.6 mg lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:47682-841
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	8.6 mg

Ingredient Name	Strength
Inactive Ingredients
CORN SYRUP (UNII: 9G5L16BK6N)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
EUCALYPTUS OIL (UNII: 2R04ONI662)
HONEY (UNII: Y9H1V576FH)
LEMON OIL (UNII: I9GRO824LL)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	yellow	Score	no score
Shape	OVAL	Size	22mm
Flavor	HONEY (Lemon)	Imprint Code	P
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:47682-841-25	125 in 1 BOX; Type 0: Not a Combination Product	03/18/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	03/18/2019

Labeler - Unifirst First Aid Corporation (832947092)

Revised: 3/2022

Document Id: da454739-60b3-28ae-e053-2a95a90a84ed

Set id: 826e1b87-e5a9-8637-e053-2991aa0aded1

Version: 5

Effective Time: 20220315

Search by Drug Name or NDC

NDC 47682-0840-25 Medi-First Honey Lemon Cough Drops 8.6 mg/1 Details

Medi-First Honey Lemon Cough Drops 8.6 mg/1

Product Information

Package

Package Images

NDC 47682-0840-25 (47682084025)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 826e1b87-e5a9-8637-e053-2991aa0aded1 Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each drop)

Purpose

Uses

Warnings

Ask a doctor before use if you have

Stop use and ask a doctor if

If pregnant or breast-feeding,

SPL UNCLASSIFIED SECTION

Directions

Other information

Inactive ingredients

Questions or comments?

Medi-First Cough Drop Label

Medi-First Plus Honey Lemon Label

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