ACTAEA RACEMOSA
- Manufacturer
- Seroyal USA | SAN’UP
- Effective date
- 2022-11-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:48:44
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients
CIMICIFUGA RACEMOSA (Black cohosh) 15CH GR
CIMICIFUGA RACEMOSA (Black cohosh) 200K GR
CIMICIFUGA RACEMOSA (Black cohosh) 30K GR
CIMICIFUGA RACEMOSA (Black cohosh) 6CH GR
CIMICIFUGA RACEMOSA (Black cohosh) 7CH GR
OTC - PURPOSE SECTION
Indications
For the temporary relief of general pre-menstrual
difficulties, and slow digestion
WARNINGS SECTION
Warning:
If pregnant or breastfeeding, ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breastfeeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
OVERDOSAGE SECTION
In case of overdose, get medical help or contact a Poison Control Center right away.
INACTIVE INGREDIENT SECTION
Inactive Ingredients
Lactose,
sucrose.
DOSAGE & ADMINISTRATION SECTION
Directions
Adults: Take five granules three times daily or as recommended by your healthcare practitioner.
Children: Take three granules and follow adult directions.
OTC - QUESTIONS SECTION
QUESTIONS? 1-888-737-6925.
INDICATIONS & USAGE SECTION
Indications
For the temporary relief of general pre-menstrual
difficulties, and slow digestion
Directions
Adults: Take five granules three times daily or as recommended by your healthcare practitioner.
Children: Take three granules and follow adult directions.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
UNDA
Do not use if label perforation is broken
Homeopathic Remedy
NDC : 62106-7200-4
CIMICIFUGA RACEMOSA
Black cohosh
140 granules
Indications
For the temporary relief of general pre-menstrual
difficulties, and slow digestion
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| BLACK COHOSH | ACTIVE INGREDIENT | K73E24S6X9 | 1 | |
| BLACK COHOSH | ACTIVE MOIETY | K73E24S6X9 | 1 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 1 |
Products#
Every source-derived product name is available through these pages.
- ACTAEA RACEMOSA
- CIMICIFUGA RACEMOSA
- BLACK COHOSH
- LACTOSE
- SUCROSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 62106-7200 | 62106-7200-4 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BLACK COHOSH | K73E24S6X9 | ACTIB |
| LACTOSE | J2B2A4N98G | IACT |
| SUCROSE | C151H8M554 | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, SUGAR COATED / ORAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 308 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | FILM, EXTENDED RELEASE / TRANSDERMAL | 675 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET / SUBLINGUAL | 109 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | GRANULE, FOR SUSPENSION / ORAL | 512.5 mg/5ml | ||
| SUCROSE | SUCROSE | C151H8M554 | TROCHE / BUCCAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | PASTILLE / ORAL | 426 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION/ DROPS / ORAL | 3750 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, DELAYED RELEASE / ORAL | 160 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, EXTENDED RELEASE / ORAL | 284.54 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET / ORAL | 2500 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, FILM COATED / ORAL | 145 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, COATED PELLETS / ORAL | 59.8 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | LOZENGE / TRANSMUCOSAL | 1255 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | SUPPOSITORY / VAGINAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | POWDER, FOR SUSPENSION / ORAL | 40017 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE, FOR SOLUTION / ORAL | 42596 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | WAFER / ORAL | 155.2 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | INJECTION / INTRAVENOUS | 203.5 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 133 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET / ORAL | 4249 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | ELIXIR / ORAL | 18000 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET / BUCCAL | 296.7 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 2000 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | POWDER, FOR SOLUTION / ORAL | 38666 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, EFFERVESCENT / ORAL | 96.5 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 18790 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | LOZENGE / BUCCAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION / ORAL | 48209 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | DROPS / ORAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION / ORAL | 31885 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY | 193.8 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, EXTENDED RELEASE / ORAL | 400 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION / SUBCUTANEOUS | 47.75 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | CREAM / VAGINAL | 3 %w/w | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET / SUBLINGUAL | 352 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | INJECTION / INTRAMUSCULAR | 203.5 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, EXTENDED RELEASE / ORAL | 619 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | POWDER / ORAL | 27768 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, COATED / ORAL | 516.42 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 86 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | INJECTION, SOLUTION / INTRAVENOUS | 0.45 %w/v | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| LACTOSE | LACTOSE | J2B2A4N98G | POWDER / VAGINAL | 430 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TROCHE / ORAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | SOLUTION / ORAL | 70000 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | CAPSULE, EXTENDED RELEASE / ORAL | 120 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, FILM COATED / ORAL | 590 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | 1 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | LIQUID / ORAL | 37500 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | POWDER / RESPIRATORY (INHALATION) | 90 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CONCENTRATE / ORAL | 4800 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION, EXTENDED RELEASE / ORAL | 5400 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SYRUP / ORAL | 46400 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET / BUCCAL | 109 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | CAPSULE, DELAYED RELEASE / ORAL | 231.84 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, EMULSION / INTRAVENOUS | 970 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 620 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | OINTMENT / TOPICAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, DELAYED RELEASE / ORAL | 295.33 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 05cf767c-0d0f-42b6-e063-6294a90a69c9 | 1716622b-18ad-5807-e054-00144ff8d46c | 2023-09-20 | Warnings | 1716622b-18ad-5807-e054-00144ff8d46c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
