D-154

D-154
SPL v3
SPL
SPL Set ID f53e05de-043c-4eb4-e053-2995a90ad9cf
Route
SUBLINGUAL
Published
Effective Date 2023-02-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oyster Shell Calcium Carbonate, Crude (12 [hp_X]) Sulfur Arabica Coffee Bean Arsenic Cation (3+) Graphite Strychnos Nux-vomica Seed Anamirta Cocculus Seed Carbonate Ion Phosphorus
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-02-21

Description

NDC 58264-0165-1


Medication Information

Warnings and Precautions
  • Use only if cap seal is unbroken.
Description

NDC 58264-0165-1

Active

Anamirta cocculus, Arabica coffee bean, Arsenicum album, Calcarea carbonica, Graphites, Kali carbonicum, Nux vomica, Phosphorus, Sulfur 6x,12x

Section 42229-5

NDC 58264-0165-1

Section 44425-7

SHAKE WELL

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

Temporary relief from symptoms associated with difficulty falling asleep or staying asleep, waking refreshed, drowsy during the day, awake at night.

Inactive

20% alcohol in purified water.

Ingredients

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-154

HOMEOPATHIC

1 FL. OZ.


Structured Label Content

Active (ACTIVE)

Anamirta cocculus, Arabica coffee bean, Arsenicum album, Calcarea carbonica, Graphites, Kali carbonicum, Nux vomica, Phosphorus, Sulfur 6x,12x

Warnings and Precautions (34071-1)
  • Use only if cap seal is unbroken.
Section 42229-5 (42229-5)

NDC 58264-0165-1

Section 44425-7 (44425-7)

SHAKE WELL

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

Temporary relief from symptoms associated with difficulty falling asleep or staying asleep, waking refreshed, drowsy during the day, awake at night.

Inactive (INACTIVE)

20% alcohol in purified water.

Ingredients (INGREDIENTS)

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-154

HOMEOPATHIC

1 FL. OZ.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)