Label: PROBIOTIC RESTORATION- aethusa cynapium, allium sativum, baptisia tinctoria, capsicum annuum, carbo vegetabilis, chamomilla, cinchona officinalis, collinsonia canadensis, colcynthis, condurango, gambogia, gratiola officinalis, lac vaccinum, lacticum acidum, natrum carbonicum, nux vomica, podophyllum peltatum, sepia, silicea liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 57955-3320-2 - Packager: King Bio Inc.
- 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 12, 2020
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ACTIVE INGREDIENT
Drug Facts
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HPUS active ingredients
Aethusa cynapium, Allium sativum, Baptisia tinctoria, Capsicum annuum, Carbo vegetabilis, Chamomilla, Cinchona officinalis, Collinsonia canadensis, Colcynthis, Condurango, Gambogia, Gratiola officinalis, Lac vaccinum, Lacticum acidum, Natrum carbonicum, Nux vomica, Podophyllum peltatum, Sepia, Silicea.
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive ingredients
Bio-Energetically Enhanced™ pure
water, citrus extract* (ascorbic
acid, citric acid, citrus aurantium
amara fruit extract, citrus
aurantium sinensis peel extract,
citrus reticulata fruit extract,
demineralized water, glycerin,
lactic acid), Honeysuckle (Lonicera
japonica), polylysine, Shagbark
Hickory (Carya ovata) Bark
Extract, steviol (Steviol
glycosides). -
PURPOSE
Drug Facts
Active ingredients ........................................................... Purpose
Equal volumes of each HPUS** ingredient in 10X, 30X, and 1LM
potencies.Aethusa cynapium........................................................ pain, colic
Allium sativum ............................voracious appetite, constipation
Baptisia tinctoria.................................bad breath, sore abdomen
Capsicum annuum ........................................................flatulence
Carbo vegetabilis.............................. nausea, burning, heaviness
and fullness in abdomen
Chamomilla ..................flatulent colic, hot, watery, or slimy stools
Cinchona officinalis.......................................gas, milk intolerance
Collinsonia canadensis........................ hemorrhoids, constipation
Colocynthis....................................................intestinal discomfort
Condurango.................................................. stomach ulcerations
Gambogia..................................abdominal pain, stomach mucus
Gratiola officinalis...................intestinal mucus, cramps and colic
Lac vaccinum .............bloating, sour taste in mouth, constipation
Lacticum acidum .............................nausea, burning gas, mucus
Natrum carbonicum...............................................weak digestion
Nux vomica...........................................................flatulence, colic
Podophyllum peltatum..........diarrhea, constipation, hemorrhoids
Sepia ................................flatulence with headache, constipation
Silicea..............................................................rumbling in bowels**“HPUS” indicates the active ingredients are in the official
Homeopathic Pharmacopeia of the United States - QUESTIONS
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INGREDIENTS AND APPEARANCE
PROBIOTIC RESTORATION
aethusa cynapium, allium sativum, baptisia tinctoria, capsicum annuum, carbo vegetabilis, chamomilla, cinchona officinalis, collinsonia canadensis, colcynthis, condurango, gambogia, gratiola officinalis, lac vaccinum, lacticum acidum, natrum carbonicum, nux vomica, podophyllum peltatum, sepia, silicea liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-3320 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AETHUSA CYNAPIUM (UNII: M6936L953C) (AETHUSA CYNAPIUM - UNII:M6936L953C) AETHUSA CYNAPIUM 10 [hp_X] in 59 mL GARLIC (UNII: V1V998DC17) (GARLIC - UNII:V1V998DC17) GARLIC 10 [hp_X] in 59 mL BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT 10 [hp_X] in 59 mL CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM 10 [hp_X] in 59 mL ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL 10 [hp_X] in 59 mL MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 10 [hp_X] in 59 mL CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK 10 [hp_X] in 59 mL COLLINSONIA CANADENSIS ROOT (UNII: O2630F3XDR) (COLLINSONIA CANADENSIS ROOT - UNII:O2630F3XDR) COLLINSONIA CANADENSIS ROOT 10 [hp_X] in 59 mL CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP 10 [hp_X] in 59 mL MARSDENIA CONDURANGO BARK (UNII: R23QIR6YBA) (MARSDENIA CONDURANGO BARK - UNII:R23QIR6YBA) MARSDENIA CONDURANGO BARK 10 [hp_X] in 59 mL GAMBOGE (UNII: 7556HJ7587) (GAMBOGE - UNII:7556HJ7587) GAMBOGE 10 [hp_X] in 59 mL GRATIOLA OFFICINALIS (UNII: BDD9991A36) (GRATIOLA OFFICINALIS - UNII:BDD9991A36) GRATIOLA OFFICINALIS 10 [hp_X] in 59 mL COW MILK (UNII: 917J3173FT) (COW MILK - UNII:917J3173FT) COW MILK 10 [hp_X] in 59 mL LACTIC ACID, DL- (UNII: 3B8D35Y7S4) (LACTIC ACID, DL- - UNII:3B8D35Y7S4) LACTIC ACID, DL- 10 [hp_X] in 59 mL SODIUM CARBONATE (UNII: 45P3261C7T) (CARBONATE ION - UNII:7UJQ5OPE7D) SODIUM CARBONATE 10 [hp_X] in 59 mL STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 10 [hp_X] in 59 mL PODOPHYLLUM (UNII: 2S713A4VP3) (PODOPHYLLUM - UNII:2S713A4VP3) PODOPHYLLUM 10 [hp_X] in 59 mL SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE 10 [hp_X] in 59 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 10 [hp_X] in 59 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CARYA OVATA BARK (UNII: X765CF609L) CITRUS BIOFLAVONOIDS (UNII: BD70459I50) LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y) POLYEPSILON-LYSINE (4000 MW) (UNII: WB0M8X4TWR) REBAUDIOSIDE A (UNII: B3FUD0528F) Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57955-3320-2 1 in 1 CARTON 03/13/2018 1 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/13/2018 Labeler - King Bio Inc. (617901350) Registrant - King Bio Inc. (617901350) Establishment Name Address ID/FEI Business Operations King Bio Inc. 617901350 api manufacture(57955-3320) , manufacture(57955-3320)