RESTLESS LEG DROPS 2172- restless leg drops liquid

Restless Leg Drops by

Drug Labeling and Warnings

Restless Leg 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

Gnaphalium polycephalum 4X
Viscum album 4X
Aconitum napellus 6X
Ignatia amara 6X
Ledum palustre 6X
Rhus toxicodendron 6X
Sulphur 6X, 12X
Magnesia phosphorica 8X
Arsenicum album 12X
Causticum 12X
Zincum metallicum 12X

QUESTIONS

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

INDICATIONS

For temporary relief of itching or tingling legs, or an impulse to move legs.*

PURPOSE

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

WARNINGS

Consult a doctor if condition worsens or if symptoms persist. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use.

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

Restless Leg Drops

Homeopathic Remedy

2 FL. OZ. (59 mL)

INGREDIENTS AND APPEARANCE

RESTLESS LEG DROPS  2172
restless leg drops liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63083-2172
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE - UNII:36XQ854NWW)	PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE	4 [hp_X]  in 59 mL
AVISCUMINE (UNII: 4B18YVW82N) (AVISCUMINE - UNII:4B18YVW82N)	AVISCUMINE	4 [hp_X]  in 59 mL
ACONITUM NAPELLUS WHOLE (UNII: U0NQ8555JD) (ACONITUM NAPELLUS WHOLE - UNII:U0NQ8555JD)	ACONITUM NAPELLUS WHOLE	6 [hp_X]  in 59 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	6 [hp_X]  in 59 mL
RHODODENDRON TOMENTOSUM LEAFY TWIG (UNII: 877L01IZ0P) (RHODODENDRON TOMENTOSUM LEAFY TWIG - UNII:877L01IZ0P)	RHODODENDRON TOMENTOSUM LEAFY TWIG	6 [hp_X]  in 59 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	6 [hp_X]  in 59 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	6 [hp_X]  in 59 mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	8 [hp_X]  in 59 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	12 [hp_X]  in 59 mL
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU)	CAUSTICUM	12 [hp_X]  in 59 mL
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS)	ZINC	12 [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: 63083-2172-2	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(63083-2172)