HERBON SUGAR FREE LEMON HONEY- menthol and echinacea purpurea lozenge

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

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Active ingredient:
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A), Echinacea Purpurea (UNII: QI7G114Y98) (Echinacea - UNII:4N9P6CC1DX)
Available from:
Purity Life Division of SunOpta Co.
INN (International Name):
Menthol
Composition:
Menthol 8 mg
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Recommended Use: For the temporary relief of cough and sore throat pain. Soothes throat irritation. Helps relieve nasal congestion and make nasal passages feel clearer. Helps shorten the duration and relieve symptoms of the common cold. DO NOT USE IF BAG IS OPEN OR TORN.
Authorization status:
OTC monograph final
Authorization number:
44597-5535-0

HERBON SUGAR FREE LEMON HONEY- menthol and echinacea purpurea lozenge

Purity Life Division of SunOpta Co.

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.

----------

INDICATIONS AND USAGE

Recommended Use: For the temporary relief of cough and sore throat pain. Soothes throat irritation.

Helps relieve nasal congestion and make nasal passages feel clearer. Helps shorten the duration and

relieve symptoms of the common cold.

Recommended Dose:

Adolescents (10 to 14 years): Dissolve 1 lozenge slowly in the mouth three times daily or more as

needed.

Adults and adolescents (14 years and older): Dissolve 1 lozenge slowly in the mouth six times daily

or more as needed.

Note: Do not exceed 14 lozenges per day. Consult a health care practitioner for use beyond eight

weeks.

Medicinal Ingredients:

Each lozenge contains:

Echinacea (Echinacea purpurea) root extract 22:1

(equivalent to 162 mg dried herb) ................................7.35 mg

Menthol (from Mentha arvensis leaf) .................................8 mg

Non-medicinal Ingredients: Natural flavours (honey lemon, lemon), natural colours (beta carotene,

curcumin), citric acid, isomalt, xylitol.

Risk Information: Consult a health care practitioner if symptoms persist or worsen, if sore throat

symptoms are severe or persist for more than two days, if cough worsens, persists for more than seven

days or is accompanied by high fever. Consult a health care practitioner prior to use if you take

immunosuppressants or have a progressive systemic disease such as tuberculosis, leukosis,

collagenosis or multiple sclerosis.

DO NOT USE IF BAG IS OPEN OR TORN.

STORE IN A COOL, DRY PLACE.

KEEP OUT OF REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL - 18 Lozenge Bag

Herbon

®

ECHINACEA Cough and Sore Throat Drops

Sugar-Free

Temporary Relief of

Cough & Sore Throat

Helps Ease Nasal Congestion

ALL NATURALLY-SOURCED

ACTIVE INGREDIENTS

LEMON HONEY

REFRESHING

BURSTS

of LEMON

18 Lozenges

HERBON SUGAR FREE LEMON HONEY

menthol and echinacea purpurea lozenge

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:4459 7-5535

Route of Administration

ORAL

Active Ingredient/Active Moiety

Purity Life Division of SunOpta Co.

Ingredient Name

Basis of Strength

Stre ng th

Mentho l (UNII: L7T10 EIP3A) (Mentho l - UNII:L7T10 EIP3A)

Me ntho l

8 mg

Echina cea Purpurea (UNII: QI7G114Y9 8 ) (Echinacea - UNII:4N9 P6 CC1DX)

Ec hina c e a

7.35 mg

Inactive Ingredients

Ingredient Name

Stre ng th

Citric Acid Mo no hydra te (UNII: 29 6 8 PHW8 QP)

16 .9 3 mg

Xylito l (UNII: VCQ0 0 6 KQ1E)

Product Characteristics

Color

YELLOW (Transulucent go lden yello w with o paque yello w speckles)

S core

no sco re

S hap e

ROUND

S iz e

20 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:4459 7-5535-0

12 in 1 CARTON

1

18 in 1 BAG

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 9 /30 /20 0 9

Labeler -

Purity Life Division of SunOpta Co. (243105843)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Purity Life Divisio n o f SunOpta Co .

24310 58 43

RELABEL, REPACK

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

F&F Labo rato ries Inc.

0 0 50 9 28 38

MANUFACTURE

Revised: 10/2009

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