Digestion

Digestion
SPL v2
SPL
SPL Set ID eabd9ea9-e61d-4c18-b95f-60c9ab1b3dd8
Route
ORAL
Published
Effective Date 2025-12-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Gentiana Lutea Root (4 [hp_X]) Sambucus Nigra Flowering Top (12 [hp_X]) Arsenic Cation (3+) Bismuth Cation Activated Charcoal Dichromate Ion Lycopodium Clavatum Spore Strychnos Nux-vomica Seed Phosphorus Anemone Pulsatilla
Inactive Ingredients
Alcohol Water Centella Asiatica Leaf

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2018-05-02

Description

ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Gentiana Lut 4X, Sambucus Nig 4X, Arsenicum Alb 12X, Bismuth Sub 12X, Carbo Veg 12X, Kali Bic 12X, Lycopodium 12X, Nux Vom 12X, Phosphorus 12X, Pulsatilla 12X.


Medication Information

Warnings and Precautions

WARNINGS:

  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
  • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
  • Do not use if TAMPER EVIDENT seal is broken or missing.
Indications and Usage

USES: Temporarily relieves distention, belching, pressure, flatulence, burning sensation, &/or other symptoms related to weak digestion.**

Dosage and Administration

DIRECTIONS: Adults & children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

Description

ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Gentiana Lut 4X, Sambucus Nig 4X, Arsenicum Alb 12X, Bismuth Sub 12X, Carbo Veg 12X, Kali Bic 12X, Lycopodium 12X, Nux Vom 12X, Phosphorus 12X, Pulsatilla 12X.

Section 34093-5

* The letters "HPUS" indicate the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Section 50565-1

KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

Section 51727-6

INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water, Gotu Kola (Hydrocotyle) Extract.

Section 51945-4

NDC: 43406-0678-1

DIGESTION

HOMEOPATHIC

 1 fl oz (30mL) / 20% Alcohol

Section 53413-1

QUESTIONS & COMMENTS?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

Section 55105-1

USES: Temporarily relieves distention, belching, pressure, flatulence, burning sensation, &/or other symptoms related to weak digestion.**

Section 55106-9

ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Gentiana Lut 4X, Sambucus Nig 4X, Arsenicum Alb 12X, Bismuth Sub 12X, Carbo Veg 12X, Kali Bic 12X, Lycopodium 12X, Nux Vom 12X, Phosphorus 12X, Pulsatilla 12X.


Structured Label Content

Indications and Usage (34067-9)

USES: Temporarily relieves distention, belching, pressure, flatulence, burning sensation, &/or other symptoms related to weak digestion.**

Dosage and Administration (34068-7)

DIRECTIONS: Adults & children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

Warnings and Precautions (34071-1)

WARNINGS:

  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
  • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
  • Do not use if TAMPER EVIDENT seal is broken or missing.
Section 34093-5 (34093-5)

* The letters "HPUS" indicate the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Section 50565-1 (50565-1)

KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water, Gotu Kola (Hydrocotyle) Extract.

Section 51945-4 (51945-4)

NDC: 43406-0678-1

DIGESTION

HOMEOPATHIC

 1 fl oz (30mL) / 20% Alcohol

Section 53413-1 (53413-1)

QUESTIONS & COMMENTS?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

Section 55105-1 (55105-1)

USES: Temporarily relieves distention, belching, pressure, flatulence, burning sensation, &/or other symptoms related to weak digestion.**

Section 55106-9 (55106-9)

ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Gentiana Lut 4X, Sambucus Nig 4X, Arsenicum Alb 12X, Bismuth Sub 12X, Carbo Veg 12X, Kali Bic 12X, Lycopodium 12X, Nux Vom 12X, Phosphorus 12X, Pulsatilla 12X.


Advanced Ingredient Data


Raw Label Data

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