FDA.reportPublic FDA data

OneLAX SENNA SYRUP Natural Vegitable Lexative Natural Choclate Flavor

Manufacturer
ATLANTIC BIOLOGICALS CORP.
Effective date
2025-12-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:29:29

Label at a glance#

ProductOneLAX SENNA
Active ingredientSENNOSIDES A AND B
Label structure9 sections

Indications and uses

relieves occasional constipation (irregularity), generally causes bowel movement in 6 to 12 hours

Dosage and administration

take preferably at bedtime or as directed by a doctor. Shake Well Before Using.

Storage and handling

Avoid accessive heat. Store at room temperature 15°-30°C (59°-86°F)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredient(in each teaspoonful)          Purpose
Sennosides 8.8 mg …………………………................Laxative

Uses

OTC - PURPOSE SECTION

relieves occasional constipation (irregularity), generally causes bowel movement in 6 to 12 hours

Warnings

WARNINGS SECTION

ask a doctor before use if you have • stomach pain • nausea • vomiting • noticed a sudden change in bowel movements that continues over a period of 2 weeks

Do not use laxative products for longer than 1 week unless directed by a doctor

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR SECTION

you are taking any other drug. Take this product two more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop use and ask a doctor if

OTC - STOP USE SECTION

you have rectal bleeding or fail to have bowel movement after use of laxative. This may indicate a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

INDICATIONS & USAGE SECTION

take preferably at bedtime or as directed by a doctor. Shake Well Before Using.

DOSAGE & ADMINISTRATION SECTION

 age starting dose maximum dosage
 Adults and children 12 yeart and older 2-3 teaspoons once a day 3 teaspoons twice a day
 Children 6 years to under 12 yeart 1 - 1 1/2teaspoons once a day  1 1/2teaspoons twice a day
 Children 2 years to under 6 yeartl/2- 3/4teaspoon once a day  3/4 teaspoon twice a day
 Children under 2 years ask a doctor ask a doctor

Other Information

STORAGE AND HANDLING SECTION

  • Avoid accessive heat. Store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

flavor choclate, mythylparaben, propylene glycol, propylparaben, purified water and sucrose

KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center immediately

Questions?

To Report Adverse Drug Event Call 1(877) 225-6999

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

LABEL 2LABEL 2

LABEL 3LABEL 3

99

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
702311sennosides 8.8 MG in 5 mL Oral SolutionPSN4
702311sennosides, USP 1.76 MG/ML Oral SolutionSCD4
702311sennosides 8.8 MG per 5 mL Oral SyrupSY4
702311sennosides, USP 26.4 MG per 15 ML Oral SolutionSY4
702311sennosides, USP 8.8 MG per 5 ML Oral SolutionSY4

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeData Matrix(01)00117856112747(21)XXXXXXXXXXX(10)XXXXXXXXXX(17)010101GTIN-14: 00117856112747
GTIN-12: 117856112747
UPC-A: 117856112747
EAN-13: 0117856112747
GTIN storage (14 digits): 00117856112747		17856-1127-04.jpg
BarcodeData Matrix(01)00317856112710(17)010101(10)XXXXXXXXXX(21)XXXXXXXXXXXGTIN-14: 00317856112710
GTIN-12: 317856112710
UPC-A: 317856112710
EAN-13: 0317856112710
GTIN storage (14 digits): 00317856112710		17856-1127-01 Rev. 2 Case Label.jpg
BarcodeData Matrix(01)00317856112796(17)010101(10)XXXXXXXXXX(21)XXXXXXXXXXXGTIN-14: 00317856112796
GTIN-12: 317856112796
UPC-A: 317856112796
EAN-13: 0317856112796
GTIN storage (14 digits): 00317856112796		17856-1127-09 Rev. 1 Case Label.jpg
BarcodeData Matrix(01)01178561127319(21)XXXXXXXXXXX(10)XXXXXXXXXX(17)010101GTIN-14: 01178561127319
GTIN-13: 1178561127319
EAN-13: 1178561127319
GTIN storage (14 digits): 01178561127319		17856-1127-03.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-1127-1OneLAX SENNA120 in 1 BOX, UNIT-DOSESYRUP1204
17856-1127-2OneLAX SENNA72 in 1 BOX, UNIT-DOSESYRUP724
17856-1127-3OneLAX SENNA72 in 1 BOX, UNIT-DOSESYRUP724
17856-1127-4OneLAX SENNA72 in 1 BOX, UNIT-DOSESYRUP724
17856-1127-5OneLAX SENNA2.5 mL in 1 SYRINGESYRUP2.54
17856-1127-6OneLAX SENNA5 mL in 1 CUP, UNIT-DOSESYRUP54
17856-1127-7OneLAX SENNA10 mL in 1 CUP, UNIT-DOSESYRUP104
17856-1127-8OneLAX SENNA15 mL in 1 CUP, UNIT-DOSESYRUP154
17856-1127-9OneLAX SENNA120 in 1 BOX, UNIT-DOSESYRUP1204
17856-1127-9OneLAX SENNA2.5 mL in 1 SYRINGESYRUP2.54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-1127-1ML - Milliliter17856-1127c08714e3-905e-4e20-97c1-043685cae09712024-06-10
17856-1127-2ML - Milliliter17856-112766cf67fe-098b-44ed-af11-ea6e69bd17a712024-06-10
17856-1127-3ML - Milliliter17856-1127e067a394-8c02-4ce9-a6a7-be9ca07d796c12024-06-10
17856-1127-4ML - Milliliter17856-1127c419747c-7cee-4a84-a0ab-0b787a39532912024-06-10
71399-0027-8ML - Milliliter71399-0027fe9b506a-3920-4704-9b2c-1015086984ee12024-03-12

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
17856-112717856-1127-5, 17856-1127-1, 17856-1127-6, 17856-1127-2, 17856-1127-7, 17856-1127-3, 17856-1127-8, 17856-1127-4, 17856-1127-9
71399-0027

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SUCROSEC151H8M554IACT
SENNOSIDES A AND B1B5FPI42ENACTIB

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
OneLAX SENNASENNAAkron Pharma Inc.27fa8f54-ed84-4afd-8da3-8754da48643b2026-09-01WarningsExact identifier
ndc (product): 71399-0027
OneLAX SENNASENNAATLANTIC BIOLOGICALS CORP.d2a5a13a-e7e4-488a-b60b-4dd467efa9712025-12-29WarningsExact identifier
ndc (package): 17856-1127-6
ndc (package): 17856-1127-9
ndc (package): 17856-1127-4
ndc (package): 17856-1127-5
ndc (package): 17856-1127-3
ndc (package): 17856-1127-7
ndc (package): 17856-1127-8
ndc (package): 17856-1127-1
ndc (package): 17856-1127-2
ndc (product): 17856-1127
ndc11 (package): 17856112704
ndc11 (package): 17856112705
ndc11 (package): 17856112701
ndc11 (package): 17856112702
ndc11 (package): 17856112703
ndc11 (package): 17856112706
ndc11 (package): 17856112708
ndc11 (package): 17856112709
ndc11 (package): 17856112707
spl id: 471b1175-9499-7889-e063-6394a90aa6dd
spl set id: d2a5a13a-e7e4-488a-b60b-4dd467efa971

Reported adverse events (FAERS/openFDA)#

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