HELONIAS COMBINATION 9227- helonias combination liquid

Helonias Combination by

Drug Labeling and Warnings

Helonias Combination 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

Viburnum opulus 2X
Apis mellifica 4X
Cimicifuga racemosa 4X
Lilium tigrinum 4X
Lycopodium clavatum 4X
Melilotus officinalis 4X
Pulsatilla 4X
Vespa crabro 4X
Helonias dioica 6X
Ammonium bromatum 8X
Aurum iodatum 12X
Chlamydia 12X
Lachesis mutus 12X
Mercurius corrosivus 12X
Naja tripudians 12X
Palladium metallicum 12X

QUESTIONS

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

INDICATIONS

For the temporary relief of mild to moderate pain, inflammation, nausea, or occasional headache associated with dysmenorrhea.*

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. 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

40% ethanol, purified water.

LABEL

Est 1985

Professional Formulas

Complementary Health

Helonias Combination

Homeopathic Remedy

1 FL. OZ. (29.5 mL)

INGREDIENTS AND APPEARANCE

HELONIAS COMBINATION  9227
helonias combination liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63083-9227
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
VIBURNUM OPULUS BARK (UNII: T1UG6H6805) (VIBURNUM OPULUS BARK - UNII:T1UG6H6805)	VIBURNUM OPULUS BARK	2 [hp_X]  in 29.5 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	4 [hp_X]  in 29.5 mL
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9)	BLACK COHOSH	4 [hp_X]  in 29.5 mL
LILIUM LANCIFOLIUM WHOLE FLOWERING (UNII: X67Z2963PI) (LILIUM LANCIFOLIUM WHOLE FLOWERING - UNII:X67Z2963PI)	LILIUM LANCIFOLIUM WHOLE FLOWERING	4 [hp_X]  in 29.5 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	4 [hp_X]  in 29.5 mL
MELILOTUS OFFICINALIS TOP (UNII: GM6P02J2DX) (MELILOTUS OFFICINALIS TOP - UNII:GM6P02J2DX)	MELILOTUS OFFICINALIS TOP	4 [hp_X]  in 29.5 mL
PULSATILLA MONTANA WHOLE (UNII: 24K790T39B) (PULSATILLA MONTANA WHOLE - UNII:24K790T39B)	PULSATILLA MONTANA WHOLE	4 [hp_X]  in 29.5 mL
VESPA CRABRO (UNII: K3ALM8S49H) (VESPA CRABRO - UNII:K3ALM8S49H)	VESPA CRABRO	4 [hp_X]  in 29.5 mL
CHAMAELIRIUM LUTEUM ROOT (UNII: DQV54Y5H3U) (CHAMAELIRIUM LUTEUM ROOT - UNII:DQV54Y5H3U)	CHAMAELIRIUM LUTEUM ROOT	6 [hp_X]  in 29.5 mL
AMMONIUM BROMIDE (UNII: R0JB3224WS) (BROMIDE ION - UNII:952902IX06)	AMMONIUM BROMIDE	8 [hp_X]  in 29.5 mL
GOLD MONOIODIDE (UNII: T1UDV7ES1A) (GOLD MONOIODIDE - UNII:T1UDV7ES1A)	GOLD MONOIODIDE	12 [hp_X]  in 29.5 mL
CHLAMYDIA TRACHOMATIS (UNII: T6NI39QU44) (CHLAMYDIA TRACHOMATIS - UNII:T6NI39QU44)	CHLAMYDIA TRACHOMATIS	12 [hp_X]  in 29.5 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	12 [hp_X]  in 29.5 mL
MERCURIC CHLORIDE (UNII: 53GH7MZT1R) (MERCURIC CATION - UNII:ED30FJ8Y42)	MERCURIC CHLORIDE	12 [hp_X]  in 29.5 mL
NAJA NAJA VENOM (UNII: ZZ4AG7L7VM) (NAJA NAJA VENOM - UNII:ZZ4AG7L7VM)	NAJA NAJA VENOM	12 [hp_X]  in 29.5 mL
PALLADIUM (UNII: 5TWQ1V240M) (PALLADIUM - UNII:5TWQ1V240M)	PALLADIUM	12 [hp_X]  in 29.5 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: 63083-9227-1	29.5 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(63083-9227)