BIO RESET JET LAG/SHIFT CHANGE- cocculus indicus, colchicum autumnale, gelsemium sempervirens, juniperus communis, kali carbonicum, kali phosphoricum nux vomica, passiflora incarnata, phosphoricum acidum, phosphorus liquid

Bio Reset Jet Lag/Shift Change by

Drug Labeling and Warnings

Bio Reset Jet Lag/Shift Change by is a Homeopathic medication manufactured, distributed, or labeled by New Sun Inc., King Bio Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Directions: Before initial dose depress pump 4-5 times or until primed and spray 1 dose directly in mouth 4 to 6 times daily until symptoms improve.

Adult Dose: 3 Pump Sprays

Child's Dose (2-12): 2 Pump Sprays

Infants - 2 yrs. 1 Pump Spray

WARNINGS

Warnings: If symptoms persist or worsen, seek advice of a physician. If pregnant or breast-feeding, take only on advice of physician.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OTHER SAFETY INFORMATION

Other information: Tamper resistant for your protection. Use only if safety seal is intact.

PURPOSE

Indications: For temporary relief of: fatigue sleeplessness irritability nervous tension spasmodic yawning drowsiness

Associated with: travel jet lag shift changing sleep pattern disturbances overworking

ACTIVE INGREDIENT

Active Ingredients: Cocculus indicus, Colchicum autumnale, Gelsemium sempervirens, Juniperus communis, Kali carbonicum, Kali phosphoricum, Nux vomica, Passiflora incarnata, Phosphoricum acidum, Phosphorus. ​Equal volumes of each ingredient in 10X, 30X, and 100X potencies.​

INACTIVE INGREDIENT

Inactive Ingredient: Citric acid, potassium sorbate, purified water.

INDICATIONS & USAGE

Indications: For temporary relief of:

• fatigue
• sleeplessness
• irritability
• nervous tension
• spasmodic yawning
• drowsiness
• travel
• jet lag
• shift changing
• sleep pattern disturbances
• overworking

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIO RESET JET LAG/SHIFT CHANGE 
cocculus indicus, colchicum autumnale, gelsemium sempervirens, juniperus communis, kali carbonicum, kali phosphoricum nux vomica, passiflora incarnata, phosphoricum acidum, phosphorus liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66579-0055
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U)	ANAMIRTA COCCULUS SEED	10 [hp_X]  in 59 mL
COLCHICUM AUTUMNALE BULB (UNII: 993QHL78E6) (COLCHICUM AUTUMNALE BULB - UNII:993QHL78E6)	COLCHICUM AUTUMNALE BULB	10 [hp_X]  in 59 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	10 [hp_X]  in 59 mL
JUNIPER BERRY (UNII: O84B5194RL) (JUNIPER BERRY - UNII:O84B5194RL)	JUNIPER BERRY	10 [hp_X]  in 59 mL
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D)	POTASSIUM CARBONATE	10 [hp_X]  in 59 mL
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR)	POTASSIUM PHOSPHATE, DIBASIC	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
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	10 [hp_X]  in 59 mL
PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN)	PHOSPHORIC ACID	10 [hp_X]  in 59 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	10 [hp_X]  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66579-0055-2	59 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/06/2011

Labeler - New Sun Inc. (957251176)

Registrant - New Sun Inc. (957251176)

Establishment
Name	Address	ID/FEI	Business Operations
King Bio Inc.		617901350	manufacture(66579-0055)