D-16

D-16
SPL v3
SPL
SPL Set ID 4784ddc2-c308-4092-a01f-ea2b2954a888
Route
SUBLINGUAL
Published
Effective Date 2018-05-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Black Cohosh (4 [hp_X]) Iris Versicolor Root (2 [hp_X]) Sanguinaria Canadensis Root (3 [hp_X]) Gelsemium Sempervirens Root Spigelia Anthelmia
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1990-01-01
Description

NDC 58264-0016-1

Medication Information

Description

NDC 58264-0016-1

Active

Cimicifuga racemosa 4x, Iris versicolor 2x, Sanguinaria canadensis 2x, Gelsemium sempervirens 3x, Spigelia anthelmia 4x

Section 42229-5

NDC 58264-0016-1

Section 44425-7

SHAKE WELL

Section 50565-1
  • Keep this and all medication out of the reach of children.
Section 53414-9
  • If pregnant or breastfeeding, ask a healthcare professional before use.
Section 55105-1

Migraine, nervous headaches.

Inactive

20% alcohol in purified water.

Suggested Dosage

One dropper under tongue two times daily. Acute symptoms ½ dropper under tongue every 30 minutes for two hours.

Principal Display Panel 1 Fl. Oz. Bottle Label

DYNAMIC

NUTRITIONAL

ASSOCIATES, INC.

D 16

HOMEOPATHIC

STRESS FORMULA

1 FL. OZ.

Structured Label Content

Active (ACTIVE)

Cimicifuga racemosa 4x, Iris versicolor 2x, Sanguinaria canadensis 2x, Gelsemium sempervirens 3x, Spigelia anthelmia 4x

Section 42229-5 (42229-5)

NDC 58264-0016-1

Section 44425-7 (44425-7)

SHAKE WELL

Section 50565-1 (50565-1)
  • Keep this and all medication out of the reach of children.
Section 53414-9 (53414-9)
  • If pregnant or breastfeeding, ask a healthcare professional before use.
Section 55105-1 (55105-1)

Migraine, nervous headaches.

Inactive (INACTIVE)

20% alcohol in purified water.

Suggested Dosage (SUGGESTED DOSAGE)

One dropper under tongue two times daily. Acute symptoms ½ dropper under tongue every 30 minutes for two hours.

Principal Display Panel 1 Fl. Oz. Bottle Label (PRINCIPAL DISPLAY PANEL - 1 FL. OZ. Bottle Label)

DYNAMIC

NUTRITIONAL

ASSOCIATES, INC.

D 16

HOMEOPATHIC

STRESS FORMULA

1 FL. OZ.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:11:54.681913 · Updated: 2026-03-14T23:17:13.532226