Minica-S

Manufacturer
Sato Pharmaceutical Co., Ltd.
Effective date
2026-06-16
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
weekly-update
Hydrated at
2026-07-17 21:42:20

Label at a glance#

ProductMINICA-S
Active ingredientGLYCERIN
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient    Glycerin 80%

OTC - PURPOSE SECTION

Purpose    Laxative

INDICATIONS & USAGE SECTION

Uses For relief of occasional consipation (irregularily). This product generally produces bowel movement in 1/4 to 1 hour.

WARNINGS SECTION

Warnings
For rectal use only   

OTC - DO NOT USE SECTION

Do not use
■for a period of longer than 1 week unless directed by a doctor. Frequent or prolonged use of this preparation may result in dependence on laxatives.   

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have
■abdominal pain, nausea, or vomiting.
■noticed a sudden change in bowel habits that persists over a period of 2 weeks.

OTC - WHEN USING SECTION

When using this product
■may cause rectal discomfort or burning sensation.

OTC - STOP USE SECTION

Stop use and ask a doctor if
■you have rectal bleeding or failure to have a bowel movement after use of a laxative. This may indicate a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions
■Adults and children 6 years and over: Use 1 rectal enema containing 8 mL of Glycerin daily or as directed by a doctor.
   Gently insert stem with tip pointing toward navel. Squeeze unit until nearly all liquid is expelled. Remove tip from rectum.
■Children under 6 years: Ask a doctor.   

OTHER SAFETY INFORMATION

Other information 
■A small amount of liquid will remain in unit.
■Store and use at room temperature.

INACTIVE INGREDIENT SECTION

Inactive ingredients  Methylparaben, purified water.   

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CARTONCARTON

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130349873032016GTIN-13: 0349873032016
EAN-13: 0349873032016
GTIN-12: 349873032016
UPC-A: 349873032016
GTIN storage (14 digits): 00349873032016
minicacart.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49873-401-012025-01-30C16284748780-12cef2736-a518-d83d-e063-dadaa90ab31fMinica-S
49873-401-012025-01-30C16284748780-12cef2736-a518-d83d-e063-dadaa90ab31fMinica-S

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
glycerinACTIVE INGREDIENTPDC6A3C0OX4
glycerinACTIVE MOIETYPDC6A3C0OX4
methylparabenINACTIVE INGREDIENTA2I8C7HI9T4
waterINACTIVE INGREDIENT059QF0KO0R4

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49873-40149873-401-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
METHYLPARABENA2I8C7HI9TIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82023-12-07full-release2026-06-01 00:04:57

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.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
methylparabenMETHYLPARABENA2I8C7HI9TENEMA / RECTAL0.18 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TENEMA / RECTAL0.18 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
MINICA-SGLYCERINSato Pharmaceutical Co., Ltd.687902eb-e702-4e87-a0ce-9add05e3cbc12026-06-16WarningsExact identifier
ndc (package): 49873-401-01
ndc (product): 49873-401
ndc11 (package): 49873040101
spl id: 54680539-3343-d78c-e063-6294a90aa416
spl set id: 687902eb-e702-4e87-a0ce-9add05e3cbc1

Reported adverse events (FAERS/openFDA)#

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