ACTIVE INGREDIENTS

Arnica montana 5C
Caulophyllum thalictroides 5C
Cimicifuga racemosa 5C
Gelsemium sempervirens 5C
Pulsatilla 5C

QUESTIONS

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

INDICATIONS

For the temporary relief of occasional headache, minor backache, swelling or aches in legs, or fatigue that is common during pregnancy.*

*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. Not intended for use in infants.

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

10% ethanol, purified water, 8% vegetable glycerin (from soy).

LABEL

Est 1985

Professional Formulas

Complementary Health

Pre-Labor Drops

Homeopathic Remedy

2 FL. OZ. (59 mL)

PRE-LABOR DROPS 2137
pre-labor drops liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63083-2137
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA WHOLE - UNII:O80TY208ZW)	ARNICA MONTANA WHOLE	5 [hp_X] in 59 mL
CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH) (CAULOPHYLLUM THALICTROIDES ROOT - UNII:JTJ6HH6YEH)	CAULOPHYLLUM THALICTROIDES ROOT	5 [hp_X] in 59 mL
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9)	BLACK COHOSH	5 [hp_X] in 59 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	5 [hp_X] in 59 mL
PULSATILLA MONTANA WHOLE (UNII: 24K790T39B) (PULSATILLA MONTANA WHOLE - UNII:24K790T39B)	PULSATILLA MONTANA WHOLE	5 [hp_X] in 59 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:63083-2137-2	59 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	08/15/1985

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

Labeler - Professional Complementary Health Formulas (167339027)

Registrant - Natural Pharmaceutical Manufacturing LLC (015624923)

Name	Address	ID/FEI	Business Operations
Establishment
Natural Pharmaceutical Manufacturing LLC		015624923	manufacture(63083-2137)

C137