FDA.reportPublic FDA data

Pulsatilla Combination

Manufacturer
Professional Complementary Health Formulas | Natural Pharmaceutical Manufacturing LLC
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-06-03 17:50:06

Label at a glance#

ProductPulsatilla Combination 9238
Active ingredientBRYONIA ALBA ROOT, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED, PULSATILLA MONTANA WHOLE, SILVER NITRATE, CITRULLUS COLOCYNTHIS FRUIT PULP, ANTIMONY TRISULFIDE, ARSENIC TRIOXIDE, ACTIVATED CHARCOAL, BOS TAURUS COLON, GIARDIA LAMBLIA, BOS TAURUS LARGE INTESTINE, MERCURIC CHLORIDE, TRIPE
Label structure9 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Bryonia 4X
Lycopodium clavatum 4X
Nux vomica 4X
Pulsatilla 4X
Argentum nitricum 6X
Colocynthis 6X
Antimonium crudum 8X
Arsenicum album 8X
Carbo vegetabilis 8X
Colon 12X
Giardia lamblia 12X
Intestine 12X
Mercurius corrosivus 12X
Stomach 12X

QUESTIONS

OTC - QUESTIONS SECTION

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

INDICATIONS

INDICATIONS & USAGE SECTION

For the temporary relief of heartburn, indigestion, or nausea.*

OTC - PURPOSE SECTION

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

WARNINGS

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

40% ethanol, purified water.

LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Est 1985

Professional Formulas

Complementary Health

Pulsatilla Combination

Homeopathic Remedy

1 FL. OZ. (29.5 mL)

Label imageLabel image

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63083-9238-12026-01-08C16284748780-11030e365-4369-111a-e063-dadaa90a10e2R238
63083-9238-12026-01-08C16284748780-11030e365-4369-111a-e063-dadaa90a10e2R238
63083-9238-12024-01-30C16284748780-11030e365-4369-111a-e063-dadaa90a10e2R238
63083-9238-12024-01-30C16284748780-11030e365-4369-111a-e063-dadaa90a10e2R238

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63083-9238-1Pulsatilla Combination923829.5 mL in 1 BOTTLE, DROPPERLIQUID29.52

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63083-923863083-9238-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
BRYONIA ALBA ROOTT7J046YI2BACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PULSATILLA MONTANA WHOLE24K790T39BACTIB
SILVER NITRATE95IT3W8JZEACTIB
CITRULLUS COLOCYNTHIS FRUIT PULP23H32AOH17ACTIB
ANTIMONY TRISULFIDEF79059A38UACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
ACTIVATED CHARCOAL2P3VWU3H10ACTIB
BOS TAURUS COLON8PD5L21RYSACTIB
GIARDIA LAMBLIA89IEJ09R73ACTIB
BOS TAURUS LARGE INTESTINED176AZC57OACTIB
MERCURIC CHLORIDE53GH7MZT1RACTIB
TRIPEC46FS57S0XACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12019-08-15full-release2026-06-01 02:15:52

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pulsatilla Combination 9238PULSATILLA COMBINATIONProfessional Complementary Health Formulasaee2e5f5-8171-4a1a-8ea0-5d78ec22c8a82026-01-08WarningsExact identifier
ndc (package): 63083-9238-1
ndc (product): 63083-9238
ndc11 (package): 63083923801
spl id: 01759f56-3b52-43df-9808-5f3b82f9a674
spl set id: aee2e5f5-8171-4a1a-8ea0-5d78ec22c8a8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.