Gastrozen

Gastrozen
SPL v1
SPL
SPL Set ID 98dd756f-6774-47c3-bdfb-deff82fb801d
Route
ORAL
Published
Effective Date 2022-12-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Coffea Arabica Seed, Roasted (4 [hp_X]) Glycyrrhiza Glabra (6 [hp_X]) Phytolacca Americana Root (12 [hp_X]) Taraxacum Officinale (30 [hp_C]) Goldenseal Arsenic Cation (3+) Gelsemium Sempervirens Root Mercurius Solubilis Nitric Acid Strychnos Nux-vomica Seed Kerosene Phosphoric Acid Phosphorus Bromine Cadmium Cation Cinchona Officinalis Bark Conium Maculatum Flowering Top Hydrogen Iodine Lachesis Muta Venom Anemone Pulsatilla Silicon Dioxide Sulfuric Acid
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2018-06-13

Description

ACTIVE INGREDIENTS (*HPUS) - equal amounts of: Coffea Tosta 4X, Glycyrrhiza 4X, Phytolacca 4X, Taraxacum 4X, Hydrastis 6X, Arsenicum Alb 12X, Gelsemium 12X, Merc Solub 12X, Nitricum Ac 12X, Nux Vom 12X, Petroleum 12X, Phosphoricum Ac 12X, Phosphorus 12X, Bromium 30C, Cadmium Sulphuricum 30C, Cinchona 30C, Conium 30C, Hydrogen 30C, Iodium 30C, Lachesis 30C, Pulsatilla 30C, Silicea 30C, Sulphuricum Ac 30C


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 minor abdominal cramps and bloating.**

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: Coffea Tosta 4X, Glycyrrhiza 4X, Phytolacca 4X, Taraxacum 4X, Hydrastis 6X, Arsenicum Alb 12X, Gelsemium 12X, Merc Solub 12X, Nitricum Ac 12X, Nux Vom 12X, Petroleum 12X, Phosphoricum Ac 12X, Phosphorus 12X, Bromium 30C, Cadmium Sulphuricum 30C, Cinchona 30C, Conium 30C, Hydrogen 30C, Iodium 30C, Lachesis 30C, Pulsatilla 30C, Silicea 30C, Sulphuricum Ac 30C

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

Section 51945-4

NDC:43406-0690-1

Gastrozen

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 minor abdominal cramps and bloating.**

Section 55106-9

ACTIVE INGREDIENTS (*HPUS) - equal amounts of: Coffea Tosta 4X, Glycyrrhiza 4X, Phytolacca 4X, Taraxacum 4X, Hydrastis 6X, Arsenicum Alb 12X, Gelsemium 12X, Merc Solub 12X, Nitricum Ac 12X, Nux Vom 12X, Petroleum 12X, Phosphoricum Ac 12X, Phosphorus 12X, Bromium 30C, Cadmium Sulphuricum 30C, Cinchona 30C, Conium 30C, Hydrogen 30C, Iodium 30C, Lachesis 30C, Pulsatilla 30C, Silicea 30C, Sulphuricum Ac 30C


Structured Label Content

Indications and Usage (34067-9)

USES: Temporarily relieves minor abdominal cramps and bloating.**

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

Section 51945-4 (51945-4)

NDC:43406-0690-1

Gastrozen

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 minor abdominal cramps and bloating.**

Section 55106-9 (55106-9)

ACTIVE INGREDIENTS (*HPUS) - equal amounts of: Coffea Tosta 4X, Glycyrrhiza 4X, Phytolacca 4X, Taraxacum 4X, Hydrastis 6X, Arsenicum Alb 12X, Gelsemium 12X, Merc Solub 12X, Nitricum Ac 12X, Nux Vom 12X, Petroleum 12X, Phosphoricum Ac 12X, Phosphorus 12X, Bromium 30C, Cadmium Sulphuricum 30C, Cinchona 30C, Conium 30C, Hydrogen 30C, Iodium 30C, Lachesis 30C, Pulsatilla 30C, Silicea 30C, Sulphuricum Ac 30C


Advanced Ingredient Data


Raw Label Data

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