UPPER GI RESTORATION- aceticum ac, agaricus musc, aloe, antimonium crud, arg nit, carbo veg, carduus mar, chelidonium maj, chenopodium anth, cinchona, graphites, ipecac, lac deflor, mentha pip, nux vom, secale, tanacetum, teucrium mar, zingiber. liquid

Upper GI Restoration by

Drug Labeling and Warnings

Upper GI Restoration by is a Homeopathic medication manufactured, distributed, or labeled by King Bio Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

HPUS active ingredients:

​Aceticum ac, Agaricus musc, Aloe, Antimon crud, Arg nit, Carbo veg, Carduus mar, Chelidonium maj, Chenopodium anth, Cinchona, Graphites, Ipecac, Lac deflor, Mentha pip, Nux vom, Secale, Tanacetum, Teucrium mar, Zingiber.

Equal volumes of each ingredient in 10X, 30X, 100X, 1LM, 2LM, 3LM, 5LM potencies.

INDICATIONS & USAGE

Uses for temporary relief of: upper gastrointestinal distress: heartburn, gas, nausea, bloating, slow digestion, flatulence, vomiting, sensitive stomach.

INACTIVE INGREDIENT

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, Carya ovata bark extract, citrus extract, Lonicer japonica (honeysuckle), polylysine, steviol glycosides

WARNINGS

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

• Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions

• Initially, depress pump until primed.
• Spray one dose directly into mouth.
• Adults: 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.

OTHER SAFETY INFORMATION

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

PURPOSE

Uses for ​temporary relief of symptoms of upper gastrointestinal distress:

• heartburn
• gas
• nausea
• bloating
• slow digestion
• flatulence
• vomiting
• sensitive stomach

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UPPER GI RESTORATION 
aceticum ac, agaricus musc, aloe, antimonium crud, arg nit, carbo veg, carduus mar, chelidonium maj, chenopodium anth, cinchona, graphites, ipecac, lac deflor, mentha pip, nux vom, secale, tanacetum, teucrium mar, zingiber. liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57955-0325
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETIC ACID (UNII: Q40Q9N063P) (ACETIC ACID - UNII:Q40Q9N063P)	ACETIC ACID	10 [hp_X]  in 59 mL
AMANITA MUSCARIA FRUITING BODY (UNII: DIF093I037) (AMANITA MUSCARIA FRUITING BODY - UNII:DIF093I037)	AMANITA MUSCARIA FRUITING BODY	10 [hp_X]  in 59 mL
ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9)	ALOE	10 [hp_X]  in 59 mL
ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY TRISULFIDE - UNII:F79059A38U)	ANTIMONY TRISULFIDE	10 [hp_X]  in 59 mL
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A)	SILVER NITRATE	10 [hp_X]  in 59 mL
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10)	ACTIVATED CHARCOAL	10 [hp_X]  in 59 mL
MILK THISTLE (UNII: U946SH95EE) (MILK THISTLE - UNII:U946SH95EE)	MILK THISTLE	10 [hp_X]  in 59 mL
CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN)	CHELIDONIUM MAJUS	10 [hp_X]  in 59 mL
DYSPHANIA AMBROSIOIDES (UNII: 4H5RSU087I) (CHENOPODIUM AMBROSIOIDES - UNII:4H5RSU087I)	DYSPHANIA AMBROSIOIDES	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
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O)	GRAPHITE	10 [hp_X]  in 59 mL
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	10 [hp_X]  in 59 mL
SKIM MILK (UNII: 6A001Y4M5A) (SKIM MILK - UNII:6A001Y4M5A)	SKIM MILK	10 [hp_X]  in 59 mL
MENTHA PIPERITA (UNII: 79M2M2UDA9) (MENTHA PIPERITA - UNII:79M2M2UDA9)	MENTHA PIPERITA	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
CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (CLAVICEPS PURPUREA SCLEROTIUM - UNII:01G9XEA93N)	CLAVICEPS PURPUREA SCLEROTIUM	10 [hp_X]  in 59 mL
TANACETUM VULGARE TOP (UNII: D52957JQ8M) (TANACETUM VULGARE TOP - UNII:D52957JQ8M)	TANACETUM VULGARE TOP	10 [hp_X]  in 59 mL
TEUCRIUM MARUM (UNII: 10464S0TAA) (TEUCRIUM MARUM - UNII:10464S0TAA)	TEUCRIUM MARUM	10 [hp_X]  in 59 mL
GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ)	GINGER	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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57955-0325-2	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/31/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/31/2018

Labeler - King Bio Inc. (617901350)

Registrant - King Bio Inc. (617901350)

Establishment
Name	Address	ID/FEI	Business Operations
King Bio Inc.		617901350	manufacture(57955-0325)