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NDC 49744-0001-01 Herplex 12; 12; 12; 12; 12; 30; 30; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 Details

Herplex 12; 12; 12; 12; 12; 30; 30; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1

Herplex is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Paradigm, Inc.. The primary component is CHRYSOPOGON ZIZANIOIDES ROOT; CLEMATIS RECTA FLOWERING TOP; DAPHNE MEZEREUM BARK; PHYTOLACCA AMERICANA ROOT; RANUNCULUS BULBOSUS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF.

Product Information

NDC	49744-0001
Product ID	49744-0001_e673de3f-7483-4b80-955a-7ffda9a12935
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	Herplex
Proprietary Name Suffix	n/a
Non-Proprietary Name	Anatherum Muricatum, Clematis Erecta, Mezereum, Phytolacca Decandra, Ranunculus Bulbosus, Rhus Tox, Thuja Occidentalis, Natrum Muriaticum, Sepia
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	12; 12; 12; 12; 12; 30; 30; 12; 12
Active Ingredient Units	[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
Substance Name	CHRYSOPOGON ZIZANIOIDES ROOT; CLEMATIS RECTA FLOWERING TOP; DAPHNE MEZEREUM BARK; PHYTOLACCA AMERICANA ROOT; RANUNCULUS BULBOSUS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF
Labeler Name	Paradigm, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	n/a

Package

Package Images

NDC 49744-0001-01 (49744000101)

Pricing Information	N/A
NDC Package Code	49744-0001-1
Billing NDC	49744000101
Package	60 TABLET in 1 BOTTLE (49744-0001-1)
Marketing Start Date	2016-09-27
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3ff89bf8-5293-4459-a47a-02d876214137 Details

ACTIVE INGREDIENTS:

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:

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

WARNINGS:

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

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

DIRECTIONS:

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:

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

INACTIVE INGREDIENTS:

Lactose, Magnesium Stearate, Microcrystalline Cellulose.

QUESTIONS OR COMMENTS:

DISTRIBUTED BY: PARADIGM, INC., LONGMONT, CO 80503

Questions or comments? 1-800-333-9325

Visit us at www.BuyHerplex.com

PACKAGE LABEL DISPLAY:

>ORAL HERPES/COLD SORES

>GENITAL HERPES

HERPLEX

A New Beginning

•Safe •Non-prescription

•Homeopathic

60 TABLETS

INGREDIENTS AND APPEARANCE

HERPLEX

anatherum muricatum, clematis erecta, mezereum, phytolacca decandra, ranunculus bulbosus, rhus tox, thuja occidentalis, natrum muriaticum, sepia tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49744-0001
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHRYSOPOGON ZIZANIOIDES ROOT (UNII: 37TB8LUP9Z) (CHRYSOPOGON ZIZANIOIDES ROOT - UNII:37TB8LUP9Z)	CHRYSOPOGON ZIZANIOIDES ROOT	12 [hp_X]
CLEMATIS RECTA FLOWERING TOP (UNII: 396421SP9F) (CLEMATIS RECTA FLOWERING TOP - UNII:396421SP9F)	CLEMATIS RECTA FLOWERING TOP	12 [hp_X]
DAPHNE MEZEREUM BARK (UNII: X2N6E405GV) (DAPHNE MEZEREUM BARK - UNII:X2N6E405GV)	DAPHNE MEZEREUM BARK	12 [hp_X]
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	12 [hp_X]
RANUNCULUS BULBOSUS (UNII: AEQ8NXJ0MB) (RANUNCULUS BULBOSUS - UNII:AEQ8NXJ0MB)	RANUNCULUS BULBOSUS	12 [hp_X]
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	12 [hp_X]
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	12 [hp_X]
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	30 [hp_X]
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	30 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	white	Score	no score
Shape	ROUND (convex)	Size	6mm
Flavor		Imprint Code	diamond
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49744-0001-1	60 in 1 BOTTLE; Type 0: Not a Combination Product	09/27/2016	04/19/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		07/22/2014	04/19/2023

Labeler - Paradigm, Inc. (078455168)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(49744-0001) , api manufacture(49744-0001) , label(49744-0001) , pack(49744-0001)

Revised: 5/2018

Document Id: e673de3f-7483-4b80-955a-7ffda9a12935

Set id: 3ff89bf8-5293-4459-a47a-02d876214137

Version: 3

Effective Time: 20180503

Search by Drug Name or NDC

NDC 49744-0001-01 Herplex 12; 12; 12; 12; 12; 30; 30; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 Details

Herplex 12; 12; 12; 12; 12; 30; 30; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1

Product Information

Package

Package Images

NDC 49744-0001-01 (49744000101)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 3ff89bf8-5293-4459-a47a-02d876214137 Details

ACTIVE INGREDIENTS:

USES:

WARNINGS:

KEEP OUT OF REACH OF CHILDREN

DIRECTIONS:

USES:

INACTIVE INGREDIENTS:

QUESTIONS OR COMMENTS:

PACKAGE LABEL DISPLAY:

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