Label: FEBRIPLEX- aconitum napellus, arnica montana, belladonna, eupatorium perfoliatum, gelsemium sempervirens, mercurius solubilis, rhus toxicodendron tablet
- NDC Code(s): 62106-9911-3
- Packager: Seroyal USA
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated November 7, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
ACTIVE INGREDIENT
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 - PURPOSE
-
WARNINGS
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. - KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
-
DOSAGE & 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. -
INDICATIONS & USAGE
Uses
For the temporary relief of flu-like symptoms accompanied by mild fever and fatigue
DirectionsAdults 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
-
INGREDIENTS AND APPEARANCE
FEBRIPLEX
aconitum napellus, arnica montana, belladonna, eupatorium perfoliatum, gelsemium sempervirens, mercurius solubilis, rhus toxicodendron tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62106-9911 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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] Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 06/26/2017 Labeler - Seroyal USA (018361118) Establishment Name Address ID/FEI Business Operations SAN’UP 401010287 manufacture(62106-9911)
