Sepia
- Manufacturer
- Boiron | Boiron, Inc.
- Effective date
- 2026-02-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 02:38:01
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient** (in each pellet)
Sepia 30C HPUS (0.44 mg)
The letters “HPUS” indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States.
OTC - PURPOSE SECTION
Purpose+
Sepia 30C HPUS (0.44 mg)……………Relieves bloating and lower back pain associated with menstruation
INDICATIONS & USAGE SECTION
Uses*
temporarily relieves symptoms associated with the premenstrual and menstrual periods such as:
- bloating
- lower back pain
OTC - STOP USE SECTION
Stop use and ask a doctor if symptoms persist for more than 3 days or worsen, new symptoms occur, or if redness or swelling is present.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
SPL UNCLASSIFIED SECTION
- do not use if glued carton end flaps are open or if pellet dispenser seal is broken
- contains 0.25 g of sugar per dose
- retain carton for full drug facts
DOSAGE & ADMINISTRATION SECTION
- Adults and children 12 years of age and older: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.
- Children under 12 years of age: Ask a doctor.
INACTIVE INGREDIENT SECTION
lactose, sucrose
OTC - QUESTIONS SECTION
BoironUSA.com
Info@Boiron.com
1-800-BOIRON-1 (1-800-264-7661)
Made in France
Distributed by Boiron Inc.
Newtown Square, PA 19073
SPL UNCLASSIFIED SECTION
PMS & MENSTRUAL SYMPTOM RELIEF*
Bloating ▪ Lower Back Pain*
1TUBE
3 TUBES
APPROX. 80 PELLETS EACH
TOTAL 240 PELLETS
How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue.
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
*C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0220-4654-41 | 2023-07-20 | C162847 | 48780-1 | f386c64a-2f70-0266-e053-dadaa90a7c1a | Sepia 30C |
| 0220-4654-41 | 2023-01-30 | C162847 | 48780-1 | f386c64a-2f70-0266-e053-dadaa90a7c1a | Sepia 30C |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0220-4654-41 | SEPIA | 30 [hp_C] in 1 TUBE | PELLET | 30 | 3 | |
| 0220-4654-43 | SEPIA | 2 in 1 CARTON | PELLET | 2 | 3 |
Products#
Every source-derived product name is available through these pages.
- SEPIA
- SEPIA OFFICINALIS JUICE
- LACTOSE, UNSPECIFIED FORM
- ANHYDROUS LACTOSE
- SUCROSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0220-4654 | 0220-4654-41, 0220-4654-43 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SEPIA OFFICINALIS JUICE | QDL83WN8C2 | ACTIB |
| LACTOSE, UNSPECIFIED FORM | J2B2A4N98G | IACT |
| SUCROSE | C151H8M554 | IACT |
Source Document#
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 |
|---|---|---|---|---|---|---|
| SEPIA | SEPIA OFFICINALIS JUICE | Boiron | 86d1f86b-db2a-0209-e053-2991aa0afec4 | 2026-02-22 | 0220-4654-43 0220-4654-41 0220-4654 00220465441 00220465443 4b715e2c-6279-2d73-e063-6394a90a0af1 86d1f86b-db2a-0209-e053-2991aa0afec4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.


