LAXACIN

Manufacturer
DIRECT RX
Effective date
2018-03-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:29:49

Label at a glance#

ProductLAXACIN
Active ingredientDOCUSATE SODIUM, SENNOSIDES A AND B
Label structure18 sections

Storage and handling

ther 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#

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 50 mg

Sennosides 8.6 mg

OTC - PURPOSE SECTION

Stool Softener

Laxative

INDICATIONS & USAGE SECTION


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

WARNINGS 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

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

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.

If pregnant or breast feeding, ask a health professional before use.

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

take preferably at bedtime or as directly 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

Other information

Each tablet contains: Calcium 20 mg
Each tablet contains: Sodium 4 mg
Store at room temperature
Keep lid tightly closed in a dry place
Do not use if imprinted safety seal under cap is broken or missing

OTC - DO NOT USE SECTION

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

Drug Facts

OTC - DO NOT USE 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 - ASK DOCTOR 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.

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

ther 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


nactive 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


uestions? 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 9006

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

497497

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


[Laxacin 10-18]

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 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61919-49761919-497-60
50488-0901

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
071193ac-34dd-244b-e063-6294a90a9e7c68526336-76bb-7eac-e053-2a91aa0a751e2023-10-06WarningsExact identifier
spl set id: 68526336-76bb-7eac-e053-2a91aa0a751e

Reported adverse events (FAERS/openFDA)#

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