Stress

Stress
SPL v1
SPL
SPL Set ID d0527396-7b7f-4252-be0f-d3aa74c25e0e
Route
ORAL
Published
Effective Date 2023-04-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
American Ginseng (6 [hp_X]) Passiflora Incarnata Flowering Top (12 [hp_X]) Scutellaria Lateriflora Whole Valerian Arsenic Cation (3+) Gold Oyster Shell Calcium Carbonate, Crude Arabica Coffee Bean Strychnos Ignatii Seed Phosphate Ion Lycopus Virginicus Phosphorus Delphinium Staphisagria Seed
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2022-09-22

Description

ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Aralia Quin 6X, Passiflora 6X, Scutellaria 6X, Valeriana 6X, Arsenicum Alb 12X, Aur Met 12X, Calc Carb 12X, Coffea Cruda 12X, Ignatia 12X, Kali Phos 12X, Lycopus 12X, Phosphorus 12X, Staphysagria 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 symptoms of simple nervous tension.**

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: Aralia Quin 6X, Passiflora 6X, Scutellaria 6X, Valeriana 6X, Arsenicum Alb 12X, Aur Met 12X, Calc Carb 12X, Coffea Cruda 12X, Ignatia 12X, Kali Phos 12X, Lycopus 12X, Phosphorus 12X, Staphysagria 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

Section 51945-4

NDC:81825-0010-1

Stress

HOMEOPATHIC

1 fl oz (30mL) / 20% Alcohol

Section 53413-1

QUESTIONS & COMMENTS?

Zorex International / Lowell, MI 49331 / 800-679-3027

Section 55105-1

USES: Temporarily relieves symptoms of simple nervous tension.**

Section 55106-9

ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Aralia Quin 6X, Passiflora 6X, Scutellaria 6X, Valeriana 6X, Arsenicum Alb 12X, Aur Met 12X, Calc Carb 12X, Coffea Cruda 12X, Ignatia 12X, Kali Phos 12X, Lycopus 12X, Phosphorus 12X, Staphysagria 12X


Structured Label Content

Indications and Usage (34067-9)

USES: Temporarily relieves symptoms of simple nervous tension.**

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:81825-0010-1

Stress

HOMEOPATHIC

1 fl oz (30mL) / 20% Alcohol

Section 53413-1 (53413-1)

QUESTIONS & COMMENTS?

Zorex International / Lowell, MI 49331 / 800-679-3027

Section 55105-1 (55105-1)

USES: Temporarily relieves symptoms of simple nervous tension.**

Section 55106-9 (55106-9)

ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Aralia Quin 6X, Passiflora 6X, Scutellaria 6X, Valeriana 6X, Arsenicum Alb 12X, Aur Met 12X, Calc Carb 12X, Coffea Cruda 12X, Ignatia 12X, Kali Phos 12X, Lycopus 12X, Phosphorus 12X, Staphysagria 12X


Advanced Ingredient Data


Raw Label Data

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