Febriplex

Febriplex
SPL v4
SPL
SPL Set ID 52e1f6ff-f4b9-693a-e054-00144ff8d46c
Route
ORAL
Published
Effective Date 2017-06-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aconitum Napellus (6 [hp_X]) Arnica Montana Root (8 [hp_X]) Atropa Belladonna (10 [hp_X]) Eupatorium Perfoliatum Flowering Top (12 [hp_X]) Gelsemium Sempervirens Root Mercurius Solubilis Toxicodendron Pubescens Shoot
Inactive Ingredients
Lactose Monohydrate Magnesium Stearate Carboxymethylcellulose Sodium Xylitol

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 9 mm Score: 1
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2017-06-26

Description

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


Medication Information

Warnings and Precautions

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.

Indications and Usage

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.

Dosage and Administration

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.

Description

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

Section 50565-1

Keep out of reach of children.

Section 51727-6

Inactive ingredients

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

Section 51945-4

NDC 62106-9911-3

UNDA plex

FEBRIPLEX(TM)

Homeopathic Preparation

For the temporary relief of flu-like symptoms.

30 Tablets

Section 53414-9

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

Section 55105-1

Uses

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

Section 55106-9

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

Section 60561-8

Other information

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

Store in a cool, dry place.


Structured Label Content

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Inactive ingredients

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

Section 51945-4 (51945-4)

NDC 62106-9911-3

UNDA plex

FEBRIPLEX(TM)

Homeopathic Preparation

For the temporary relief of flu-like symptoms.

30 Tablets

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Uses

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

Section 55106-9 (55106-9)

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

Section 60561-8 (60561-8)

Other information

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

Store in a cool, dry place.


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Raw Label Data

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