SPRAYOLOGY TRAVELEASE- apis mellifica, carbo vegetabilis, carduus marianus, cocculus indicus, ignatia amara, nux vomica, passifl

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

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Active ingredient:
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z), ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10), SILYBUM MARIANUM SEED (UNII: U946SH95EE) (SILYBUM MARIANUM SEED - UNII:U946SH95EE), ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U), STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K), STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919), PASSIFLORA INCAR
Available from:
Eight and Company
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
For use during and after jet travel to temporarily relieve the symptoms commonly known as "jet lag", including: - tiredness - dehydration - feeling of disorientation - sleeplessness For use during and after jet travel to temporarily relieve the symptoms commonly known as "jet lag", including: ° tiredness ° dehydration ° feeling of disorientation ° sleeplessness ° natural ° gluten free ° no artificial flavors or colors ° no known negative side effects ° no known negative drug interactions
Authorization status:
unapproved homeopathic
Authorization number:
61096-0007-1

SPRAYOLOGY TRAVELEASE- apis mellifica, carbo vegetabilis, carduus marianus, cocculus

indicus, ignatia amara, nux vomica, passiflora incarnata, tabacum liquid

Eight and Company

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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Sprayology TravelEase

Active Ingredients: Apis mellifica 200C, Carbo vegetabilis 200C, Carduus marianus 3X, Cocculus

Indicus 30C, Ignatia amara 200C, Nux vomica 30C, Passiflora incarnata 1X, Tabacum 6X.

Warnings: If symptoms persist or worsen, stop use and seek advice of physician. If pregnant or

breast-feeding, ask a health care professional before use. Keep out of reach of children. Contains

alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

Keep out of reach of children.

For use during and after jet travel to temporarily relieve the symptoms commonly known as "jet lag",

including:

tiredness

dehydration

feeling of disorientation

sleeplessness

Directions :

Adults and children over 12: 2 sprays under the tongue at departure, after each 2 hours of flight and

on landing. Then 2 sprays 3 times a day until fully acclimated.

Children 2 to 12: 1 spray under tongue at departure, after each 2 hours of flight and on landing. Then

1 spray 3 times a day until fully acclimated.

Under age 2: consult a health care professional.

Other Information: Do not use if the transparent seal around spray bottle is broken or missing.

Inactive Ingredients: Glycerin 10%, v/v, non-GMO organic alcohol 9% v/v, purified water.

For use during and after jet travel to temporarily relieve the symptoms commonly known as "jet lag",

including:

° tiredness

° dehydration

° feeling of disorientation

° sleeplessness

° natural

° gluten free

° no artificial flavors or colors

° no known negative side effects

° no known negative drug interactions

SPRAYOLOGY TRAVELEASE

apis mellifica, carbo vegetabilis, carduus marianus, cocculus indicus, ignatia amara, nux vomica, passiflora

incarnata, tabacum liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 10 9 6 -0 0 0 7

Route of Administration

ORAL

Active Ingredient/Active Moiety

Eight and Company

Ingredient Name

Basis of Strength

Stre ng th

APIS MELLIFERA (UNII: 7S8 2P3R43Z) (APIS MELLIFERA - UNII:7S8 2P3R43Z)

APIS MELLIFERA

20 0 [hp_C]

in 41 mL

ACTIVATED CHARCO AL (UNII: 2P3VWU3H10 ) (ACTIVATED CHARCOAL -

UNII:2P3VWU3H10 )

ACTIVATED CHARCOAL

20 0 [hp_C]

in 41 mL

SILYBUM MARIANUM SEED (UNII: U9 46 SH9 5EE) (SILYBUM MARIANUM SEED -

UNII:U9 46 SH9 5EE)

SILYBUM MARIANUM SEED

3 [hp_X]

in 41 mL

ANAMIRTA CO CCULUS SEED (UNII: 8 10 258 W28 U) (ANAMIRTA COCCULUS SEED -

UNII:8 10 258 W28 U)

ANAMIRTA COCCULUS

SEED

30 [hp_C]

in 41 mL

STRYCHNO S IGNATII SEED (UNII: 1NM3M248 7K) (STRYCHNOS IGNATII SEED -

UNII:1NM3M248 7K)

STRYCHNOS IGNATII SEED

20 0 [hp_C]

in 41 mL

STRYCHNO S NUX-VO MICA SEED (UNII: 26 9 XH139 19 ) (STRYCHNOS NUX-VOMICA

SEED - UNII:26 9 XH139 19 )

STRYCHNOS NUX-VOMICA

SEED

30 [hp_C]

in 41 mL

PASSIFLO RA INCARNATA FLO WERING TO P (UNII: CLF5YFS11O) (PASSIFLORA

INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)

PASSIFLORA INCARNATA

FLOWERING TOP

1 [hp_X]

in 41 mL

TO BACCO LEAF (UNII: 6 YR26 0 8 RSU) (TOBACCO LEAF - UNII:6 YR26 0 8 RSU)

TOBACCO LEAF

6 [hp_X]

in 41 mL

Inactive Ingredients

Ingredient Name

Stre ng th

GLYCERIN (UNII: PDC6 A3C0 OX)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 10 9 6 -0 0 0 7-1

1 in 1 CARTON

1

41 mL in 1 BOTTLE, SPRAY

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

0 1/22/20 14

Labeler -

Eight and Company (927364120)

Registrant -

Eight and Company (927364120)

Revised: 1/2014

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