DIGESTIVEASE- arsenicum alb, calc sulph, carbo an, carbo veg, cinchona, hydrastis, nox vom, ornithogalum, pyrogenium, silicea liquid 
Eight and Company L.L.C

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:

ACTIVE INGREDIENTS:

Arsenicum alb 200C, Calc sulph 200C, Carbo an 12X, Carbo veg 12X, Cinchona 200C, Hydrastis 12X, Nox vomica 200C, Ornithogalum 12X, Pyrogenium 200, Silicea 12X.

PURPOSE:

Temporarily relieves symptoms of gastric distress, including:

° nausea and food poisoning
° flatulence
° indigestion and heartburn
° stomach cramps

WARNINGS:

Keep box for indications and other warnings.

If symptoms persist or worsen, 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:

Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

Adults and children over 12: 2 sprays into the mouth each 30 minutes as needed for symptom relief the first day, 2 sprays 3 times a day thereafter. Under age 12 consult a health care professional.

OTHER INFORMATION:

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

INDICATIONS:

Temporarily relieves symptoms of gastric distress, including:

° nausea and food poisoning

° flatulence

° indigestion and heartburn

° stomach cramps

° natural

° gluten & lactose free

° no artificial flavors or colors

° no known negative side effects

° no known negative drug interactions

INACTIVE INGREDIENTS:

 Non-GMO glycerin, organic alcohol 20% v/v, purified water.

QUESTIONS:

Mfd. for Eight and Company L.L.C.

Gaithersburg, MD 20879 1.800.377.5787

www.sprayology.com

PACKAGE LABEL DISPLAY:

Sprayology

DigestivEase

RELIEVES STOMACH DISTRESS

HOMEOPATHIC ORAL SPRAY

1.38 fl. oz (41 ml)

DigestivEase LBL

DigestivEase CTN

DIGESTIVEASE 
arsenicum alb, calc sulph, carbo an, carbo veg, cinchona, hydrastis, nox vom, ornithogalum, pyrogenium, silicea liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61096-1005
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE200 [hp_C]  in 41 mL
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SULFATE ANHYDROUS200 [hp_C]  in 41 mL
CARBO ANIMALIS (UNII: 279O8I0433) (CARBO ANIMALIS - UNII:279O8I0433) CARBO ANIMALIS12 [hp_X]  in 41 mL
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL12 [hp_X]  in 41 mL
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK200 [hp_C]  in 41 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL12 [hp_X]  in 41 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED200 [hp_C]  in 41 mL
ORNITHOGALUM UMBELLATUM (UNII: 9NS3M2Y78S) (ORNITHOGALUM UMBELLATUM - UNII:9NS3M2Y78S) ORNITHOGALUM UMBELLATUM12 [hp_X]  in 41 mL
RANCID BEEF (UNII: 29SUH5R3HU) (RANCID BEEF - UNII:29SUH5R3HU) RANCID BEEF200 [hp_C]  in 41 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_X]  in 41 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61096-1005-11 in 1 CARTON04/24/2019
141 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/24/2019
Labeler - Eight and Company L.L.C (927364120)
Registrant - Apotheca Company (844330915)

Revised: 2/2021
Document Id: 21fa541f-7ef4-40e1-8989-56a8f1af9880
Set id: 70840ff7-75c0-44a0-9eb8-b36f13518af2
Version: 2
Effective Time: 20210210
 
Eight and Company L.L.C