DIGESTIVEASE- arsenicum alb, calc sulph, carbo an, carbo veg, cinchona, hydrastis, nox vom, ornithogalum, pyrogenium, silicea liquid

DigestivEase by

Drug Labeling and Warnings

DigestivEase by is a Homeopathic medication manufactured, distributed, or labeled by Eight and Company L.L.C, Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

WARNINGS

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.

DOSAGE & ADMINISTRATION

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.

PURPOSE

Temporarily relieves symptoms of gastric distress, including:

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

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT

Inactive Ingredients: Non-GMO glycerin v/v, norganic alcohol 20% v/v and purified water.

INDICATIONS & USAGE

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIGESTIVEASE 
arsenicum alb, calc sulph, carbo an, carbo veg, cinchona, hydrastis, nox vom, ornithogalum, pyrogenium, silicea liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61096-1005
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	200 [hp_C]  in 41 mL
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM SULFATE ANHYDROUS	200 [hp_C]  in 41 mL
CARBO ANIMALIS (UNII: 279O8I0433) (CARBO ANIMALIS - UNII:279O8I0433)	CARBO ANIMALIS	12 [hp_X]  in 41 mL
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10)	ACTIVATED CHARCOAL	12 [hp_X]  in 41 mL
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB)	CINCHONA OFFICINALIS BARK	200 [hp_C]  in 41 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	12 [hp_X]  in 41 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	200 [hp_C]  in 41 mL
ORNITHOGALUM UMBELLATUM (UNII: 9NS3M2Y78S) (ORNITHOGALUM UMBELLATUM - UNII:9NS3M2Y78S)	ORNITHOGALUM UMBELLATUM	12 [hp_X]  in 41 mL
RANCID BEEF (UNII: 29SUH5R3HU) (RANCID BEEF - UNII:29SUH5R3HU)	RANCID BEEF	200 [hp_C]  in 41 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	12 [hp_X]  in 41 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61096-1005-1	1 in 1 CARTON	04/24/2019
1		41 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/24/2019

Labeler - Eight and Company L.L.C (927364120)

Registrant - Eight and Company L.L.C (927364120)