INSOMNIA DROPS 2035- insomnia drops liquid

Insomnia Drops by

Drug Labeling and Warnings

Insomnia Drops by is a Homeopathic medication manufactured, distributed, or labeled by Professional Complementary Health Formulas, Natural Pharmaceutical Manufacturing LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Chamomilla 1X
Valeriana officinalis 1X
Avena sativa 2X
Zincum metallicum 3X
Passiflora incarnata 6X
Coffea cruda 6X, 12X, 30X
Paullinia sorbilis 24X

QUESTIONS

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

INDICATIONS

For the temporary relief of difficulty falling or staying asleep.*

PURPOSE

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS

In case of overdose, get medical help or contact a poison control center right away.

Keep out of the reach of children.

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

DIRECTIONS

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day for up to 6 weeks. For immediate onset of symptoms, take 10 to 15 drops every 15 minutes up to 3 hours. For less severe symptoms, take 10-15 drops hourly up to 8 hours. Consult a physician for use in children under 12 years of age.

OTHER INFORMATION

Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

INACTIVE INGREDIENTS

20% ethanol, purified water.

LABEL

Est 1985

Professional Formulas

Complementary Health

Insomnia Drops

Homeopathic Remedy

2 FL. OZ. (59 mL)

INGREDIENTS AND APPEARANCE

INSOMNIA DROPS  2035
insomnia drops liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63083-2035
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARTEMISIA ANNUA FLOWERING TOP (UNII: 0UQK6O82OW) (ARTEMISIA ANNUA FLOWERING TOP - UNII:0UQK6O82OW)	ARTEMISIA ANNUA FLOWERING TOP	1 [hp_X]  in 59 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	1 [hp_X]  in 59 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	2 [hp_X]  in 59 mL
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS)	ZINC	3 [hp_X]  in 59 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	6 [hp_X]  in 59 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	6 [hp_X]  in 59 mL
PAULLINIA CUPANA SEED (UNII: C21GE7524R) (PAULLINIA CUPANA SEED - UNII:C21GE7524R)	PAULLINIA CUPANA SEED	24 [hp_X]  in 59 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63083-2035-2	59 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	08/15/1985

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/15/1984

Labeler - Professional Complementary Health Formulas (167339027)

Registrant - Natural Pharmaceutical Manufacturing LLC (015624923)

Establishment
Name	Address	ID/FEI	Business Operations
Natural Pharmaceutical Manufacturing LLC		015624923	manufacture(63083-2035)