Lower GI Restoration™

LOWER GI RESTORATION- aethusa cynapium, allium sativum, baptisia tinctoria, capsicum annuum, carbo vegetabilis, chamomilla, cinchona officinalis, collinsonia canadensis, colocynthis, condurango, gambogia, gratiola officinalis, lac vaccinum, lacticum acidum, natrum carbonicum, nux vomica, podophyllum peltaum, sepia, silicea liquid
King Bio Inc.

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.

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Drug Facts__________________________________________________________________________________________________________

HPUS active ingredients: Aethusa cynapium, Allium sativum, Baptisia tinctoria, Capsicum annuum, Carbo vegetabilis, Chamomilla, Cinchona officinalis, Collinsonia canadensis, Colocynthis, Condurango, Gambogia, Gratiola officinalis, Lac vaccinum, Lacticum acidum, Natrum carbonicum, Nux vomica, Podophyllum peltaum, Sepia, Silicea. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.

Uses for temporary relief of symptoms of lower gastrointestinal distress: gas bloating, constipation, hemorrhoids, abdominal cramping, diarrhea, flatulence, gastrointestinal inflammation.

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

Warnings

Stop use and ask your doctor if symptoms persist or worsen.
If pregnant or breast-feeding, take only on advice of a healthcare professional.

Keep out of reach of children.

Directions

Initially, depress pump until primed.
Spray one dose directly into mouth.
Adults 12 and up: 3 sprays 3 times per day.
Children 2-12 years: 2 sprays 3 times per day.
Use additionally as needed, up to 6 times per day.

Tamper resistant for your protection. Use only if safety seal is intact. This product has not been clinically tested.

Uses for temporary relief of symptoms of lower gastrointestinal distress:

gas bloating
constipation
hemorrhoids
abdominal cramping
diarrhea
flatulence
gastrointestinal inflammation

image description

LOWER GI RESTORATION
aethusa cynapium, allium sativum, baptisia tinctoria, capsicum annuum, carbo vegetabilis, chamomilla, cinchona officinalis, collinsonia canadensis, colocynthis, condurango, gambogia, gratiola officinalis, lac vaccinum, lacticum acidum, natrum carbonicum, nux vomica, podophyllum peltaum, sepia, silicea liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57955-0322
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57955-0322-2	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/08/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		04/08/2016

Labeler - King Bio Inc. (617901350)

Registrant - King Bio Inc. (617901350)

Name	Address	ID/FEI	Business Operations
Establishment
King Bio Inc.		617901350	manufacture(57955-0322)