Search by Drug Name or NDC

NDC 62106-9911-03 FEBRIPLEX 6; 8; 8; 10; 12; 10; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 Details

FEBRIPLEX 6; 8; 8; 10; 12; 10; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1

FEBRIPLEX is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Seroyal USA. The primary component is ACONITUM NAPELLUS; ARNICA MONTANA ROOT; ATROPA BELLADONNA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; MERCURIUS SOLUBILIS; TOXICODENDRON PUBESCENS SHOOT.

Product Information

NDC	62106-9911
Product ID	62106-9911_eceb2ab1-7e67-dd8c-e053-2a95a90aa848
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	FEBRIPLEX
Proprietary Name Suffix	n/a
Non-Proprietary Name	Aconitum napellus, Arnica montana, Belladonna, Eupatorium perfoliatum, Gelsemium sempervirens, Mercurius solubilis, Rhus toxicodendron
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	6; 8; 8; 10; 12; 10; 8
Active Ingredient Units	[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
Substance Name	ACONITUM NAPELLUS; ARNICA MONTANA ROOT; ATROPA BELLADONNA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; MERCURIUS SOLUBILIS; TOXICODENDRON PUBESCENS SHOOT
Labeler Name	Seroyal USA
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 62106-9911-03 (62106991103)

Pricing Information	N/A
NDC Package Code	62106-9911-3
Billing NDC	62106991103
Package	1 BLISTER PACK in 1 BOX (62106-9911-3) / 30 TABLET in 1 BLISTER PACK
Marketing Start Date	2017-06-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 52e1f6ff-f4b9-693a-e054-00144ff8d46c Details

SPL UNCLASSIFIED SECTION

Active ingredients

Each tablet contains:

Aconitum napellus (Aconite) Whole Plant 6X

Arnica montana (Mountain arnica) Underground Parts 8X

Belladonna (Deadly nightshade) Whole Plant 8X

(<1.43 x 10-10% alkaloids, calculated)

Eupatorium perfoliatum (Boneset) Aerial Parts 10X

Gelsemium sempervirens (Yellow jessamine) Underground Parts 12X

Mercurius solubilis (Hahnemann's soluble mercury) 10X

Rhus toxicodendron (Poison Ivy) Leafy Unwoody Twigs 8X

SPL UNCLASSIFIED SECTION

Uses

For the temporary relief of flu-like symptoms accompanied by mild fever and fatigue.

SPL UNCLASSIFIED SECTION

Warnings

Stop use and ask a doctor if symptoms continue to persist

after three days of use or are accompanied by a fever.

Do not use if you have ever had an allergic reaction to this

product or any of its ingredients.

If pregnant or breastfeeding, ask a health professional

before use. Keep out of reach of children. In case of overdose,

get medical help or contact a Poison Control Center right away.

SPL UNCLASSIFIED SECTION

Keep out of reach of children.

SPL UNCLASSIFIED SECTION

If pregnant or breastfeeding, ask a health professional before use.

SPL UNCLASSIFIED SECTION

Other information

Do not use if the blister pack has been tampered with.

Store in a cool, dry place.

SPL UNCLASSIFIED SECTION

Inactive ingredients

Lactose monohydrate (milk), magnesium stearate, sodium carboxymethylcellulose, xylitol

SPL UNCLASSIFIED SECTION

Directions

Adults and adolescents (12 years and older):

At the first sign of symptoms, take one tablet allowing it to

dissolve under the tongue. Continue every half hour to one hour.

When symptoms subside, decrease frequency to every four hours.

Once the symptoms are gone, continue taking one tablet daily for three more days.

Children (under 12 years):

Take under the direction of your healthcare practitioner.

SPL UNCLASSIFIED SECTION

Uses

For the temporary relief of flu-like symptoms accompanied by mild fever and fatigue

Directions

Adults and adolescents (12 years and older):

At the first sign of symptoms, take one tablet allowing it to

dissolve under the tongue. Continue every half hour to one hour.

When symptoms subside, decrease frequency to every four hours.

Once the symptoms are gone, continue taking one tablet daily for three more days.

Children (under 12 years):

Take under the direction of your healthcare practitioner.

PRINCIPAL DISPLAY PANEL

NDC 62106-9911-3

UNDA plex

FEBRIPLEX(TM)

Homeopathic Preparation

For the temporary relief of flu-like symptoms.

30 Tablets

INGREDIENTS AND APPEARANCE

FEBRIPLEX

aconitum napellus, arnica montana, belladonna, eupatorium perfoliatum, gelsemium sempervirens, mercurius solubilis, rhus toxicodendron tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62106-9911
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	6 [hp_X]
ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327)	ARNICA MONTANA ROOT	8 [hp_X]
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	8 [hp_X]
EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E)	EUPATORIUM PERFOLIATUM FLOWERING TOP	10 [hp_X]
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	12 [hp_X]
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2)	MERCURIUS SOLUBILIS	10 [hp_X]
TOXICODENDRON PUBESCENS SHOOT (UNII: 46PYZ1F82M) (TOXICODENDRON PUBESCENS SHOOT - UNII:46PYZ1F82M)	TOXICODENDRON PUBESCENS SHOOT	8 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:62106-9911-3	1 in 1 BOX	06/26/2017
1		30 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		06/26/2017

Labeler - Seroyal USA (018361118)

Name	Address	ID/FEI	Business Operations
Establishment
SAN’UP		401010287	manufacture(62106-9911)

Revised: 11/2022

Document Id: eceb2ab1-7e67-dd8c-e053-2a95a90aa848

Set id: 52e1f6ff-f4b9-693a-e054-00144ff8d46c

Version: 4

Effective Time: 20221107

Search by Drug Name or NDC

NDC 62106-9911-03 FEBRIPLEX 6; 8; 8; 10; 12; 10; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 Details

FEBRIPLEX 6; 8; 8; 10; 12; 10; 8 [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 62106-9911-03 (62106991103)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 52e1f6ff-f4b9-693a-e054-00144ff8d46c Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

Questions About Combining Hydroxyzine And Buspirone

Can You Take A Z-Pak If You Have A Penicillin Allergy?