drug facts:

drug facts:
SPL v2
SPL
SPL Set ID 056ac695-82d3-4164-9123-79520b5deecc
Route
oral
Published
Effective Date 2018-09-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
echinacea angustifolia (3 [hp_X]) phosphate ion (6 [hp_X]) colchicum autumnale bulb (8 [hp_X]) arsenic cation (3+) (9 [hp_X]) citrullus colocynthis fruit pulp (12 [hp_X]) croton tiglium seed (16 [hp_X]) gamboge acetic acid antimony trisulfide bismuth cation cinchona officinalis bark iron iris versicolor root skim milk mercury strychnos nux-vomica seed ricinus communis seed veratrum album root escherichia coli proteus mirabilis
Inactive Ingredients
water alcohol

Identifiers & Packaging

Marketing Status
unapproved homeopathic completed Since 2018-09-26 Until 2028-12-01

Description

Echinacea (Angustifolia) 3X, Natrum Phosphoricum 6X, Colchicum Autumnale 8X, Arsenicum Album 8X, 12X 30X, Colocynthis 9X, Croton Tiglium 9X, Gambogia 9X, Aceticum Acidum 12X, Antimonium Crudum 12X, Bismuthum Subnitricum 12X, Cinchona Officinalis 12X, Ferrum Metallicum 12X, Iris Versicolor 12X, Lac Defloratum 12X, Mercurius Vivus 12X, Nux Vomica 12X, Ricinus Communis 12X, Veratrum Album 12X, Colibacillinum Cum Natrum Muriaticum 16X, Proteus (Mirabilis) 16X.


Medication Information

Description

Echinacea (Angustifolia) 3X, Natrum Phosphoricum 6X, Colchicum Autumnale 8X, Arsenicum Album 8X, 12X 30X, Colocynthis 9X, Croton Tiglium 9X, Gambogia 9X, Aceticum Acidum 12X, Antimonium Crudum 12X, Bismuthum Subnitricum 12X, Cinchona Officinalis 12X, Ferrum Metallicum 12X, Iris Versicolor 12X, Lac Defloratum 12X, Mercurius Vivus 12X, Nux Vomica 12X, Ricinus Communis 12X, Veratrum Album 12X, Colibacillinum Cum Natrum Muriaticum 16X, Proteus (Mirabilis) 16X.

Warnings:

Keep out of reach of children. In case of overdose, contact physician or Poison Control Center right away.

If pregnant or breast-feeding, ask a health professional before use.

Tamper seal: "Sealed for Your Protection." Do not use if seal is broken or missing.

Questions:

Dist. By: Deseret Biologicals, Inc.

469 W. Parkland Drive

Sandy, UT 84070 www.desbio.com

Directions:

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

Active Ingredients:

Echinacea (Angustifolia) 3X, Natrum Phosphoricum 6X, Colchicum Autumnale 8X, Arsenicum Album 8X, 12X 30X, Colocynthis 9X, Croton Tiglium 9X, Gambogia 9X, Aceticum Acidum 12X, Antimonium Crudum 12X, Bismuthum Subnitricum 12X, Cinchona Officinalis 12X, Ferrum Metallicum 12X, Iris Versicolor 12X, Lac Defloratum 12X, Mercurius Vivus 12X, Nux Vomica 12X, Ricinus Communis 12X, Veratrum Album 12X, Colibacillinum Cum Natrum Muriaticum 16X, Proteus (Mirabilis) 16X.

Inactive Ingredients:

Demineralized Water, 25% Ethanol.

Package Label Display:

DESBIO

NDC 43742-1304-1

HOMEOPATHIC

GI DISTRESS

1 FL OZ (30 ml)

Homeopathic Indications:

For the temporary relief of symptoms related to occasional watery diarrhea, irritation of stomach, indigestion, abdominal bloating, stomach cramps, and loss of appetite.**

**These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

Keep Out of Reach of Children:

Keep out of reach of children. In case of overdose, contact physician or Poison Control Center right away.


Structured Label Content

Warnings: (WARNINGS:)

Keep out of reach of children. In case of overdose, contact physician or Poison Control Center right away.

If pregnant or breast-feeding, ask a health professional before use.

Tamper seal: "Sealed for Your Protection." Do not use if seal is broken or missing.

Questions: (QUESTIONS:)

Dist. By: Deseret Biologicals, Inc.

469 W. Parkland Drive

Sandy, UT 84070 www.desbio.com

Directions: (DIRECTIONS:)

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

Active Ingredients: (ACTIVE INGREDIENTS:)

Echinacea (Angustifolia) 3X, Natrum Phosphoricum 6X, Colchicum Autumnale 8X, Arsenicum Album 8X, 12X 30X, Colocynthis 9X, Croton Tiglium 9X, Gambogia 9X, Aceticum Acidum 12X, Antimonium Crudum 12X, Bismuthum Subnitricum 12X, Cinchona Officinalis 12X, Ferrum Metallicum 12X, Iris Versicolor 12X, Lac Defloratum 12X, Mercurius Vivus 12X, Nux Vomica 12X, Ricinus Communis 12X, Veratrum Album 12X, Colibacillinum Cum Natrum Muriaticum 16X, Proteus (Mirabilis) 16X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

DESBIO

NDC 43742-1304-1

HOMEOPATHIC

GI DISTRESS

1 FL OZ (30 ml)

Homeopathic Indications: (HOMEOPATHIC INDICATIONS:)

For the temporary relief of symptoms related to occasional watery diarrhea, irritation of stomach, indigestion, abdominal bloating, stomach cramps, and loss of appetite.**

**These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

Keep Out of Reach of Children: (KEEP OUT OF REACH OF CHILDREN:)

Keep out of reach of children. In case of overdose, contact physician or Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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