Sprayology Digestivease

Sprayology Digestivease
SPL v1
SPL
SPL Set ID 2dcdfbbc-05e3-4626-a7b6-79660101f2c0
Route
ORAL
Published
Effective Date 2014-03-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arsenic Cation (3+) (200 [hp_C]) Calcium Cation (12 [hp_X]) Carbo Animalis Activated Charcoal Cinchona Officinalis Bark Goldenseal Strychnos Nux-vomica Seed Ornithogalum Umbellatum Rancid Beef Colloidal Silicon Dioxide
Inactive Ingredients
Glycerin Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2014-03-17

Description

Active Ingredients: Arsenicum album 200C, Calcarea sulphurica 200C, Carbo animalis 12X, Carbo vegetabilis 12X, Cinchona officinalis 200C, Hydrastis canadensis 12X, Nox vomica 200C, Ornithogalum 12X, Pyrogenium 200, Silicea 12X


Medication Information

Warnings and Precautions

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.

Indications and Usage

Temporarily relieves symptoms of gastric distress, including:

° nausea and food poisoning

° flatulence

° indigestion and heartburn

° stomach cramps

° natural

° gluten free

° no artificial flavors or colors

° no known negative side effects

° no known negative drug interactions

Dosage and 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.
  • Ages 2 to 12: 1 spray into the mouth each 30 minutes as needed for symptom relief the first day, 1 spray 3 times a day thereafter. Under age 2: consult a health care professional.
Description

Active Ingredients: Arsenicum album 200C, Calcarea sulphurica 200C, Carbo animalis 12X, Carbo vegetabilis 12X, Cinchona officinalis 200C, Hydrastis canadensis 12X, Nox vomica 200C, Ornithogalum 12X, Pyrogenium 200, Silicea 12X

Section 50565-1

Keep out of reach of children.

Section 51727-6

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

Section 51945-4

Section 55105-1

Temporarily relieves symptoms of gastric distress, including:

  • nausea and food poisoning
  • flatulence
  • indigestion and heartburn
  • stomach cramps
Section 55106-9

Active Ingredients: Arsenicum album 200C, Calcarea sulphurica 200C, Carbo animalis 12X, Carbo vegetabilis 12X, Cinchona officinalis 200C, Hydrastis canadensis 12X, Nox vomica 200C, Ornithogalum 12X, Pyrogenium 200, Silicea 12X

Section 60561-8

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


Structured Label Content

Indications and Usage (34067-9)

Temporarily relieves symptoms of gastric distress, including:

° nausea and food poisoning

° flatulence

° indigestion and heartburn

° stomach cramps

° natural

° gluten free

° no artificial flavors or colors

° no known negative side effects

° no known negative drug interactions

Dosage and Administration (34068-7)

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.
  • Ages 2 to 12: 1 spray into the mouth each 30 minutes as needed for symptom relief the first day, 1 spray 3 times a day thereafter. Under age 2: consult a health care professional.
Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Temporarily relieves symptoms of gastric distress, including:

  • nausea and food poisoning
  • flatulence
  • indigestion and heartburn
  • stomach cramps
Section 55106-9 (55106-9)

Active Ingredients: Arsenicum album 200C, Calcarea sulphurica 200C, Carbo animalis 12X, Carbo vegetabilis 12X, Cinchona officinalis 200C, Hydrastis canadensis 12X, Nox vomica 200C, Ornithogalum 12X, Pyrogenium 200, Silicea 12X

Section 60561-8 (60561-8)

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


Advanced Ingredient Data


Raw Label Data

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