FDA.reportPublic FDA data

Only For

Manufacturer
O4 Global Trading Usa, Llc
Effective date
2019-04-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:59:22

Label at a glance#

ProductOnly For STIMULANT LAXATIVE
Active ingredientSENNOSIDES
Label structure10 sections

Indications and uses

• relieves occasional constipation (irregularity) • generally causes a bowel movement in 6‐12 hours

Dosage and administration

• do not take more than directed  • take with full glass of water • take preferably at bedtime or as directed by a doctor  Age Starting dosage  Maximum dosage                      adults and children 12 years of age and over   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 ...

Storage and handling

• Store at room temperature between 20-25°C (68-77°F).

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Sennosides 8.6 mg

Purpose

OTC - PURPOSE SECTION

Stimulant laxative

Uses:

INDICATIONS & USAGE SECTION

• relieves occasional constipation (irregularity)

• generally causes a bowel movement in 6‐12 hours

Warnings:

WARNINGS SECTION

Do not use:

• 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 continue 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.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions:

DOSAGE & ADMINISTRATION SECTION

• do not take more than directed  • take with full glass of water

• take preferably at bedtime or as directed by a doctor

 AgeStarting dosage Maximum dosage 
                    adults and children 12 years of age and over  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

Other Information:

STORAGE AND HANDLING SECTION

• Store at room temperature between 20-25°C (68-77°F).

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl methyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol.

Questions Or Comments ?

OTC - QUESTIONS SECTION

1-833-665-9444.

SPL UNCLASSIFIED SECTION

Distributed By: O4 GLOBAL TRADING USA LLC., 2241 S Watson RD, Suite 121 Arlington, TX 76010.

www.onlyfor.com

Packaged By: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING

Tear along perforation push product through foil

CT2LXN4-REV.102018

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312935sennosides 8.6 MG Oral TabletPSN1
312935sennosides, USP 8.6 MG Oral TabletSCD1
312935sennosides A and B 8.6 MG Oral TabletSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73006-112-412022-01-28C16284748780-1d6a99b39-35d5-a426-e053-dadaa90af4c2Only For - STIMULANT LAXATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73006-112-41Only ForSTIMULANT LAXATIVE4 in 1 BLISTER PACKTABLET41
73006-112-41Only ForSTIMULANT LAXATIVE1 in 1 CARTONTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73006-112ONLY FOR STIMULANT LAXATIVE (SENNOSIDES) TABLET [O4 GLOBAL TRADING USA, LLC ]1Legacy NDC, 2 package rows20190430_94a2acd4-5a94-4ce6-9180-38dad80ed20c.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73006-11273006-112-41

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
SENNOSIDES3FYP5M0IJXACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4IACT
MAGNESIUM PALMITOSTEARATER4OXA9G5BVIACT
MICROCRYSTALLINE CELLULOSE 1017T9FYH5QMKIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
76a6d4cc-f0a4-49ea-857c-6ec9ffe03b8794a2acd4-5a94-4ce6-9180-38dad80ed20c2019-04-25WarningsExact identifier
spl id: 76a6d4cc-f0a4-49ea-857c-6ec9ffe03b87
spl set id: 94a2acd4-5a94-4ce6-9180-38dad80ed20c

Reported adverse events (FAERS/openFDA)#

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