JET LAG - alumina, aralia quinquefolia, arg. nit., arnica, arsenicum alb., baptisia, bryonia, cantharis, chelidonium majus, coni

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Aluminum Oxide (UNII: LMI26O6933) (Aluminum Oxide - UNII:LMI26O6933), American Ginseng (UNII: 8W75VCV53Q) (American Ginseng - UNII:8W75VCV53Q), Silver Nitrate (UNII: 95IT3W8JZE) (Silver Cation - UNII:57N7B0K90A), Arnica Montana (UNII: O80TY208ZW) (Arnica Montana - UNII:O80TY208ZW), Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV), Baptisia Tinctoria (UNII: 5K1UO2888Y) (Baptisia Tinctoria - UNII:5K1UO2888Y), Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B)
Available from:
Newton Laboratories, Inc.
INN (International Name):
Aluminum Oxide
Composition:
Aluminum Oxide 15 [hp_X] in 1 mL
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Jet Lag   Formulated for symptoms associated with travel such as fatigue, insomnia, headaches and digestive discomfort. Formulated for symptoms associated with travel such as fatigue, insomnia, headaches and digestive discomfort.
Authorization status:
unapproved homeopathic
Authorization number:
55714-1110-0, 55714-1110-1, 55714-1110-2

JET LAG - alumina, aralia quinquefolia, arg. nit., arnica, arsenicum alb., baptisia, bryonia,

cantharis, chelidonium majus, conium, gelsemium, iodium, kali carb., kali iod., lycopodium,

lycopus virginicus, nat. mur., nux vom., phosphorus, phytolacca, pulsatilla, rhus toxicodendron,

sabal, thyroidinum, echinacea liquid

Newton Laboratories, 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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Jet Lag

INDICATIONS & USAGE SECTION

Jet Lag Formulated for symptoms associated with travel such as fatigue, insomnia, headaches and

digestive discomfort.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 drops orally (ages 0 to 11,

give 3 drops) as needed or as directed by a healthcare professional. Sensitive persons begin with 1

drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Alumina 15x, Aralia quinquefolia 15x, Arg. nit. 15x, Arnica 15x, Arsenicum alb. 15x, Baptisia 15x,

Bryonia 15x, Cantharis 15x, Chelidonium majus 15x, Conium 15x, Gelsemium 15x, Iodium 15x, Kali

carb. 15x, Kali iod. 15x, Lycopodium 15x, Lycopus virginicus 15x, Nat. mur. 15x, Nux vom. 15x,

Phosphorus 15x, Phytolacca 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Sabal 15x, Thyroidinum 15x,

Echinacea 3x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with travel such as fatigue, insomnia, headaches and digestive

discomfort.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing

alcohol 20%.

QUESTIONS SECTION

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012

Questions? 1.800.448.7256

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare

professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out

of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for

more than a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

JET LAG

alumina, aralia quinquefolia, arg. nit., arnica, arsenicum alb., baptisia, bryonia, cantharis, chelidonium majus,

conium, gelsemium, iodium, kali carb., kali iod., lycopodium, lycopus virginicus, nat. mur., nux vom., phosphorus,

phytolacca, pulsatilla, rhus toxicodendron, sabal, thyroidinum, echinacea liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:55714-1110

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Aluminum O xide (UNII: LMI26 O6 9 33) (Aluminum Oxide - UNII:LMI26 O6 9 33)

Aluminum Oxide

15 [hp_X]

in 1 mL

America n Ginseng (UNII: 8 W75VCV53Q) (American Ginseng - UNII:8 W75VCV53Q)

American Ginseng

15 [hp_X]

in 1 mL

Silver Nitra te (UNII: 9 5IT3W8 JZE) (Silver Catio n - UNII:57N7B0 K9 0 A)

Silver Nitrate

15 [hp_X]

in 1 mL

Arnica Mo nta na (UNII: O8 0 TY20 8 ZW) (Arnica Mo ntana - UNII:O8 0 TY20 8 ZW)

Arnica Mo ntana

15 [hp_X]

in 1 mL

Arsenic Trio xide (UNII: S7V9 2P6 7HO) (Arsenic Catio n (3+) - UNII:C9 6 6 13F5AV)

Arsenic Trio xide

15 [hp_X]

in 1 mL

Ba ptisia Tincto ria (UNII: 5K1UO28 8 8 Y) (Baptisia Tincto ria - UNII:5K1UO28 8 8 Y)

Baptisia Tincto ria

15 [hp_X]

in 1 mL

Bryo nia Alba Ro o t (UNII: T7J0 46 YI2B) (Bryo nia Alba Ro o t - UNII:T7J0 46 YI2B)

Bryo nia Alba Ro o t

15 [hp_X]

in 1 mL

Lytta Vesica to ria (UNII: 3Q0 34RO3BT) (Lytta Vesicato ria - UNII:3Q0 34RO3BT)

Lytta Vesicato ria

15 [hp_X]

in 1 mL

Chelido nium Ma j us (UNII: 7E8 8 9 U5RNN) (Chelido nium Majus - UNII:7E8 8 9 U5RNN)

Chelido nium Majus

15 [hp_X]

in 1 mL

Co nium Ma cula tum Flo wering To p (UNII: Q28 R5GF371) (Co nium Maculatum Flo wering

To p - UNII:Q28 R5GF371)

Co nium Maculatum

Flo wering To p

15 [hp_M]

in 1 mL

Gelsemium Sempervirens Ro o t (UNII: 6 39 KR6 0 Q1Q) (Gelsemium Sempervirens Ro o t -

UNII:6 39 KR6 0 Q1Q)

Gelsemium Sempervirens

Ro o t

15 [hp_X]

in 1 mL

Io dine (UNII: 9 6 79 TC0 7X4) (Io dine - UNII:9 6 79 TC0 7X4)

Io dine

15 [hp_X]

in 1 mL

Po ta ssium Ca rbo na te (UNII: BQN1B9 B9 HA) (Carbo nate Io n - UNII:7UJQ5OPE7D)

Po tassium Carbo nate

15 [hp_X]

in 1 mL

Po ta ssium Io dide (UNII: 1C4QK22F9 J) (Io dide Io n - UNII:0 9 G4I6 V8 6 Q)

Po tassium Io dide

15 [hp_X]

in 1 mL

Lyco po dium Cla va tum Spo re (UNII: C8 8 X29 Y479 ) (Lyco po dium Clavatum Spo re -

UNII:C8 8 X29 Y479 )

Lyco po dium Clavatum

Spo re

15 [hp_X]

in 1 mL

Lyco pus Virg inicus (UNII: TWH5125Q6 F) (Lyco pus Virginicus - UNII:TWH5125Q6 F)

Lyco pus Virginicus

15 [hp_X]

in 1 mL

So dium Chlo ride (UNII: 451W47IQ8 X) (Chlo ride Io n - UNII:Q32ZN48 6 9 8 )

So dium Chlo ride

15 [hp_X]

in 1 mL

Strychno s Nux-vo mica Seed (UNII: 26 9 XH139 19 ) (Strychno s Nux-vo mica Seed -

UNII:26 9 XH139 19 )

Strychno s Nux-vo mica

Se e d

15 [hp_X]

in 1 mL

Pho spho rus (UNII: 27YLU75U4W) (Pho spho rus - UNII:27YLU75U4W)

Pho spho rus

15 [hp_X]

in 1 mL

Phyto la cca America na Ro o t (UNII: 11E6 VI8 VEG) (Phyto lacca Americana Ro o t -

UNII:11E6 VI8 VEG)

Phyto lacca Americana

Ro o t

15 [hp_X]

in 1 mL

Pulsa tilla Vulg a ris (UNII: I76 KB35JEV) (Pulsatilla Vulgaris - UNII:I76 KB35JEV)

Pulsatilla Vulgaris

15 [hp_X]

in 1 mL

To xico dendro n Pubescens Lea f (UNII: 6 IO18 2RP7A) (To xico dendro n Pubescens Leaf -

UNII:6 IO 18 2RP7A)

To xico dendro n Pubescens

Le a f

15 [hp_X]

in 1 mL

Sa w Pa lmetto (UNII: J7WWH9 M8 QS) (Saw Palmetto - UNII:J7WWH9 M8 QS)

Saw Palmetto

15 [hp_X]

in 1 mL

Thyro id, Unspecified (UNII: 0 B4FDL9 I6 P) (Thyro id, Unspecified - UNII:0 B4FDL9 I6 P)

Thyro id, Unspecified

15 [hp_X]

in 1 mL

Echina cea , Unspecified (UNII: 4N9 P6 CC1DX) (Echinacea, Unspecified -

UNII:4N9 P6 CC1DX)

Echinacea, Unspecified

3 [hp_X]

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Alco ho l (UNII: 3K9 9 58 V9 0 M)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:55714-1110 -1

29 .57 mL in 1 BOTTLE, GLASS

2

NDC:55714-1110 -2

59 .14 mL in 1 BOTTLE, GLASS

3

NDC:55714-1110 -0

.5 mL in 1 BOTTLE, GLASS

Marketing Information

Newton Laboratories, Inc.

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

0 3/0 1/20 11

Labeler -

Newton Laboratories, Inc. (788793610)

Registrant -

Newton Laboratories, Inc. (788793610)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Newto n Labo rato ries, Inc.

78 8 79 36 10

MANUFACTURE(55714-1110 )

Revised: 3/2011

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