FDA.reportPublic FDA data

Laxacin

Manufacturer
Alexso, Inc
Effective date
2024-12-04
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:40:46

Label at a glance#

ProductLaxacin
Active ingredientDOCUSATE SODIUM, SENNOSIDES A AND B
Label structure16 sections

Storage and handling

Other information each tablet contains: calcium 20 mg, sodium 4 mg keep lid tightly closed store at room temperature in a dry place

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each tablet)

Docusate Sodium 50 mg

Sennosides 8.6 mg

OTC - PURPOSE SECTION

Purposes

Stool softener

Laxative

INDICATIONS & USAGE SECTION

Uses

  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 6-12 hours

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not use

  • if you are now taking mineral oil, unless directed by a doctor
  • laxative products for longer than 1 week unless directed by a doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that continues over a period of 2 weeks

OTC - STOP USE SECTION

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

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • take preferably at bedtime or as directed by a doctor

age

starting dose

maximum dose

adults and children 12

years and older

2 tablets once a day

4 tablets twice a day

children 6 to under 12 years

1 tablet once a day

2 tablets twice a day

children 2 to under 6 years

1/2 tablet once a day

1 tablet twice a day

children under 2 years

ask a doctor

ask a doctor

STORAGE AND HANDLING SECTION

Other information

  • each tablet contains: calcium 20 mg, sodium 4 mg
  • keep lid tightly closed
  • store at room temperature in a dry place

INACTIVE INGREDIENT SECTION

Inactive ingredients Croscarmellose sodium, D&C yellow #10, dextrose, dicalcium phosphate, FD&C yellow #6, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silica, sodium benzoate, stearic acid, titanium dioxide.

OTC - QUESTIONS SECTION

Questions? If you have any questions or comments, or to report an adverse event, please contact (800) 495-6078

SPL UNCLASSIFIED SECTION

Manufactured for:

Alexso Inc.

Los Angeles, CA 90064

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 50488-0901-1

Laxacin

(laxastimucin)

Laxative Plus Stool Softener

Standardized Senna Concentrate 8.6 mg and Docusate Sodium 50 mg Each

Fast, Dependable Relief

Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye)

100 Tablets

Laxacin 10-18
Laxacin 10-18

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2106884Laxacin 50 MG / 8.6 MG Oral TabletPSN8
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN8
2106884docusate sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet [Laxacin]SBD8
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD8
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY8
2106884DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet [Laxacin]SY8
2106884Laxacin 50 MG / 8.6 MG Oral TabletSY8

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50488-0901-1Laxacin100 in 1 BOTTLETABLET1008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50488-0901LAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ALEXSO, INC]8Current NDC, Legacy NDC, 1 package rows20241208_0df9abaf-3997-4dde-8003-ae3d8d07cf39.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50488-0901-1EA - Each50488-0901933d71c3-b01d-44ff-b256-0bee20827ae812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA01
SENNOSIDES A AND BACTIVE INGREDIENT1B5FPI42EN1
DOCUSATEACTIVE MOIETYM7P27195AG1
SENNOSIDESACTIVE MOIETY3FYP5M0IJX1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92J1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH481
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3G1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W21
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A81
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50488-090150488-0901-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOCUSATE SODIUMF05Q2T2JA0ACTIB
SENNOSIDES A AND B1B5FPI42ENACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SODIUM BENZOATEOJ245FE5EUIACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SILICON DIOXIDEETJ7Z6XBU4IACT

Source Document#

Source XML · Source PDF

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 · 22 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET / ORAL30 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATEANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET / ORAL2240 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET / ORAL30 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2TABLET / ORAL183.66 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET / ORAL80 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2TABLET / ORAL183.66 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / ORAL60.02 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / ORAL60.02 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET / ORAL80 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATEANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET / ORAL2240 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact 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
LaxacinDOCUSATE SODIUM AND SENNOSIDESAlexso, Inc0df9abaf-3997-4dde-8003-ae3d8d07cf392024-12-04WarningsExact identifier
ndc (package): 50488-0901-1
ndc (product): 50488-0901
ndc11 (package): 50488090101
spl id: 1b45f6d1-4436-4b3a-813b-7043c0d0fad6
spl set id: 0df9abaf-3997-4dde-8003-ae3d8d07cf39

Reported adverse events (FAERS/openFDA)#

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