Label: PAEONIA PLEX- aesculus hippocastanum,arnica montana, graphites, hamamelis virginiana, nitricum acidum, nux vomica, paeonia officinalis, sulphur liquid
- NDC Code(s): 62106-1198-0
- 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 October 9, 2020
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active ingredients
Each drop contains:
Aesculus hippocastanum (Horse chestnut) Seeds 3X
Arnica montana (Leopard's bane) Underground Parts 4CH
Graphites (Black lead) 4CH
Hamamelis virginiana (Witch hazel) Bark 4X
Nitricum acidum (Nitric acid) 4CH
Nux vomica (Poison nut) Seeds 4CH (<2.7 x 10-9 % alkaloids, calculated)
Paeonia officinalis (Peony) Underground Parts 4X
Sulphur (Sublimed sulfur) 6X - PURPOSE
- WARNINGS
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
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DOSAGE & ADMINISTRATION
Directions
To be taken ten minutes away from food.
Invert bottle and shake lightly allowing drops to fall directly under the tongue or into ¼ oz of water.
Hold contents for about 20 seconds and swallow.
To promote drop flow, invert bottle and shake before each use.
Dosage frequency may be increased up to six times daily depending on the severity of symptoms.Adults and adolescents (12 years and older)
Take 10 drops three times daily or as recommended by your healthcare practitioner
Children (under 12 years)
Take under the direction of your healthcare practitioner.
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INDICATIONS & USAGE
Uses
Assists with the temporary relief of hemorrhoids.
Helps promote and maintain healthy liver function.Directions
To be taken ten minutes away from food.
Invert bottle and shake lightly allowing drops to fall directly under the tongue or into ¼ oz of water.
Hold contents for about 20 seconds and swallow.
To promote drop flow, invert bottle and shake before each use.
Dosage frequency may be increased up to six times daily depending on the severity of symptoms.Adults and adolescents (12 years and older)
Take 10 drops three times daily or as recommended by your healthcare practitioner.
Children (under 12 years)
Take under the direction of your healthcare practitioner.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PAEONIA PLEX
aesculus hippocastanum,arnica montana, graphites, hamamelis virginiana, nitricum acidum, nux vomica, paeonia officinalis, sulphur liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62106-1198 Route of Administration SUBLINGUAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327) ARNICA MONTANA ROOT 4 [hp_C] in 30 mL GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE 4 [hp_C] in 30 mL HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY) (HAMAMELIS VIRGINIANA BARK - UNII:IH3063S9MY) HAMAMELIS VIRGINIANA BARK 4 [hp_X] in 30 mL PAEONIA OFFICINALIS ROOT (UNII: 8R564U2E1P) (PAEONIA OFFICINALIS ROOT - UNII:8R564U2E1P) PAEONIA OFFICINALIS ROOT 4 [hp_X] in 30 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 6 [hp_X] in 30 mL STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 4 [hp_C] in 30 mL NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4) NITRIC ACID 4 [hp_C] in 30 mL HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT 3 [hp_X] in 30 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62106-1198-0 1 in 1 CARTON 10/20/2015 1 30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 10/20/2015 Labeler - Seroyal USA (018361118) Establishment Name Address ID/FEI Business Operations SAN'UP 401010287 manufacture(62106-1198)
