Laxacin Tablets

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:50:23

Label at a glance#

ProductLaxacin
Active ingredientDOCUSATE SODIUM, SENNOSIDES A AND B
Label structure17 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 ifyou 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 ingredientsCroscarmellose 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

HOW SUPPLIED SECTION

Laxacin tablets are supplied as follows:

Bottles of 100 tablets NDC: 80425-0345-01

SPL UNCLASSIFIED SECTION

Manufactured for:

Alexso Inc.

Los Angeles, CA 90064

Distributed by:

Advanced Rx Pharmacy of Tennessee, LLC

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label 1label 1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2106884Laxacin 50 MG / 8.6 MG Oral TabletPSN2
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN2
2106884docusate sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet [Laxacin]SBD2
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD2
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY2
2106884DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet [Laxacin]SY2
2106884Laxacin 50 MG / 8.6 MG Oral TabletSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0345-1Laxacin100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0345LAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 1 package rows20250102_fe7d4d75-0f8a-1e7d-e053-6394a90afb4d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0345-1EA - Each80425-0345e0d5b825-9e4b-4852-9fdc-de636a46689f12023-07-06
50488-0901-1EA - Each50488-0901933d71c3-b01d-44ff-b256-0bee20827ae812012-07-24

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
80425-034580425-0345-1
50488-0901

Ingredients#

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

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

Source Document#

Source XML

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LaxacinDOCUSATE SODIUM AND SENNOSIDESAdvanced Rx Pharmacy of Tennessee, LLCfe7d4d75-0f8a-1e7d-e053-6394a90afb4d2024-12-31WarningsExact identifier
ndc (package): 80425-0345-1
ndc (product): 80425-0345
ndc11 (package): 80425034501
spl id: 2a9c2eb6-a6dc-f647-e063-6294a90a93fe
spl set id: fe7d4d75-0f8a-1e7d-e053-6394a90afb4d
LaxacinDOCUSATE SODIUM AND SENNOSIDESAlexso, Inc0df9abaf-3997-4dde-8003-ae3d8d07cf392024-12-04WarningsExact identifier
ndc (product): 50488-0901

Reported adverse events (FAERS/openFDA)#

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