D-16- black cohosh, iris versicolor root, sanguinaria canadensis root, gelsemium sempervirens root, and spigelia anthelmia solution/ drops
DNA Labs, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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D-16

NDC 58264-0016-1

INDICATIONS

Migraine, nervous headaches.

INGREDIENTS

ACTIVE

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

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.

SHAKE WELL

Warnings

Use only if cap seal is unbroken.

If pregnant or breastfeeding, ask a healthcare professional before use.

Keep this and all medication out of the reach of children.

To be used according to standard homeopathic indications.

PRINCIPAL DISPLAY PANEL - 1 FL. OZ. Bottle Label

DYNAMIC
NUTRITIONAL
ASSOCIATES, INC.

D 16

HOMEOPATHIC
STRESS FORMULA

1 FL. OZ.

D-16
black cohosh, iris versicolor root, sanguinaria canadensis root, gelsemium sempervirens root, and spigelia anthelmia solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58264-0016
Route of Administration	SUBLINGUAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9)	BLACK COHOSH	4 [hp_X] in 1 mL
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC)	IRIS VERSICOLOR ROOT	2 [hp_X] in 1 mL
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508)	SANGUINARIA CANADENSIS ROOT	2 [hp_X] in 1 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	3 [hp_X] in 1 mL
SPIGELIA ANTHELMIA (UNII: WYT05213GE) (SPIGELIA ANTHELMIA - UNII:WYT05213GE)	SPIGELIA ANTHELMIA	4 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58264-0016-1	29.57 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	01/01/1990

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/01/1990

Labeler - DNA Labs, Inc. (031784339)