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#

ProductSEPIA
Active ingredientSEPIA OFFICINALIS JUICE
Label structure12 sections

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

LABELLABEL

LABELLABEL

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0220-4654-412023-07-20C16284748780-1f386c64a-2f70-0266-e053-dadaa90a7c1aSepia 30C
0220-4654-412023-01-30C16284748780-1f386c64a-2f70-0266-e053-dadaa90a7c1aSepia 30C

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-4654-41SEPIA30 [hp_C] in 1 TUBEPELLET303
0220-4654-43SEPIA2 in 1 CARTONPELLET23

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-46540220-4654-41, 0220-4654-43

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Source Document#

Source XML · Source PDF

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
SEPIASEPIA OFFICINALIS JUICEBoiron86d1f86b-db2a-0209-e053-2991aa0afec42026-02-22Exact identifier
ndc (package): 0220-4654-43
ndc (package): 0220-4654-41
ndc (product): 0220-4654
ndc11 (package): 00220465441
ndc11 (package): 00220465443
spl id: 4b715e2c-6279-2d73-e063-6394a90a0af1
spl set id: 86d1f86b-db2a-0209-e053-2991aa0afec4

Reported adverse events (FAERS/openFDA)#

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