FDA.reportPublic FDA data

Herplex

Manufacturer
Prime Time Solutions, Inc. | Apotheca Company
Effective date
2022-03-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:06:44

Label at a glance#

ProductHerplex
Active ingredientCHRYSOPOGON ZIZANIOIDES ROOT, CLEMATIS RECTA FLOWERING TOP, DAPHNE MEZEREUM BARK, PHYTOLACCA AMERICANA ROOT, RANUNCULUS BULBOSUS, TOXICODENDRON PUBESCENS LEAF, THUJA OCCIDENTALIS LEAFY TWIG, SODIUM CHLORIDE, SEPIA OFFICINALIS JUICE
Label structure9 sections

Indications and uses

Herplex can be used for temporarily relieving outbreaks of cold sores and genital herpes.

Dosage and administration

For use only after diagnoses by a physician, as follows: Cold Sores/Oral Herpes: Take 3 tablets immediately at the first sign of burning or itching and then 3 tablets three times daily until symptoms disappear. Genital Herpes: For severe genital herpes sufferers, take 3 to 5 tablets 3 times daily for prevention of outbreaks. If you have an outbreak that does not subside within 10 days, consult your doctor. For mil...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Anatherum Muricatum 12X, Clematis Erecta 12X, Mezereum 12X, Phytolacca Decandra 12X, Ranunculus Bulbosus 12X, Rhus Toxicodendron 12X, Thuja Occidentalis 12X, Natrum Muriaticum 30X, Sepia 30X.

USES:

OTC - PURPOSE SECTION

Herplex can be used for temporarily relieving outbreaks of cold sores and genital herpes.

WARNINGS:

WARNINGS SECTION

Do not use unless you have been diagnosed by a physician with oral herpes or genital herpes.

CAUTION: Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Not recommended for children under 12.

If you are pregnant or breast-feeding, ask your doctor before use.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SHRINK SEAL AROUND NECK AND CAP IS BROKEN OR MISSING.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

For use only after diagnoses by a physician, as follows:

Cold Sores/Oral Herpes: Take 3 tablets immediately at the first sign of burning or itching and then 3 tablets three times daily until symptoms disappear.

Genital Herpes: For severe genital herpes sufferers, take 3 to 5 tablets 3 times daily for prevention of outbreaks. If you have an outbreak that does not subside within 10 days, consult your doctor. For mild to moderate symptoms, take 3 tablets immediately at the first sign of burning or itching, and then 3 tablets three times daily until symptoms disappear. If symptoms do not subside within 10 days, consult your doctor.

USES:

INDICATIONS & USAGE SECTION

Herplex can be used for temporarily relieving outbreaks of cold sores and genital herpes.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Lactose, Magnesium Stearate, Microcrystalline Cellulose.

QUESTIONS OR COMMENTS:

OTC - QUESTIONS SECTION

DISTRIBUTED BY: Prime Time Solutions, Inc., Torrington, CT 06790

Questions or comments? 1-800-333-9325

Visit us at www.BuyHerplex.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

>ORAL HERPES/COLD SORES
>GENITAL HERPES

HERPLEX

A New Beginning

•Safe •Non-prescription

•Homeopathic

60 TABLETS

HerplexHerplex

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72277-000172277-0001-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHRYSOPOGON ZIZANIOIDES ROOT37TB8LUP9ZACTIB
CLEMATIS RECTA FLOWERING TOP396421SP9FACTIB
DAPHNE MEZEREUM BARKX2N6E405GVACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
RANUNCULUS BULBOSUSAEQ8NXJ0MBACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f650e162-6d2c-46b6-800d-1454d2ce0eae2dae0ac4-5f2d-41f2-aa89-9fd3b422d78b2022-03-08WarningsExact identifier
spl id: f650e162-6d2c-46b6-800d-1454d2ce0eae
spl set id: 2dae0ac4-5f2d-41f2-aa89-9fd3b422d78b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.