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OneLAX SENNA

OneLAX SENNA SYRUP Natural Vegitable Lexative Natural Choclate Flavor

Approved
Approval ID

d2a5a13a-e7e4-488a-b60b-4dd467efa971

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 23, 2025

Manufacturers
FDA

ATLANTIC BIOLOGICALS CORP.

DUNS: 047437707

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

SENNA

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code17856-1127
Application NumberM007
Product Classification
M
Marketing Category
C200263
G
Generic Name
SENNA
Product Specifications
Route of AdministrationORAL
Effective DateMay 23, 2025
FDA Product Classification

INGREDIENTS (6)

METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SENNOSIDES A AND BActive
Quantity: 417.12 mg in 237 mL
Code: 1B5FPI42EN
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 3/5/2024

LABEL 1

LABEL 2

LABEL 3

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 3/5/2024

Directions

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 3/5/2024

Active Ingredient

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

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 3/5/2024

Uses

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

WARNINGS SECTION

LOINC: 34071-1Updated: 3/5/2024

Warnings

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

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

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,

ask a health professional before use.

Keep out of reach of children

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 3/5/2024

** 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 yeart

l/2- 3/4teaspoon once a day

3/4 teaspoon twice a day

Children under 2 years

ask a doctor

ask a doctor

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 3/5/2024

Other Information

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 3/5/2024

Inactive Ingredients

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 3/5/2024

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

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OneLAX SENNA - FDA Drug Approval Details