LAXACIN

Manufacturer
Direct_Rx
Effective date
2023-10-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:24:54

Label at a glance#

ProductLAXACIN
Active ingredientSENNOSIDES A AND B, DOCUSATE SODIUM
Label structure15 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

Manufactured for:

Alexso Inc.

Los Angeles, CA 90064

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

497-71497-71

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-497-60EA - Each61919-4979edaf6d7-a5ef-4535-8fb6-97f933fd7fcb12019-03-12
61919-497-71EA - Each61919-497c615305f-f5c7-4389-904a-318bdbb1b29812019-09-05
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 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61919-49761919-497-71
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 SENNOSIDESAlexso, Inc0df9abaf-3997-4dde-8003-ae3d8d07cf392024-12-04WarningsExact identifier
ndc (product): 50488-0901
074cbd37-1450-7d3b-e063-6294a90a340f912f7025-3bc7-3673-e053-2a95a90adbc22023-10-09WarningsExact identifier
spl set id: 912f7025-3bc7-3673-e053-2a95a90adbc2

Reported adverse events (FAERS/openFDA)#

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