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FDA Approval

OneLAX SENNA

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
May 23, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Sennosides(417.12 mg in 237 mL)

Products1

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

OneLAX SENNA

Product Details

NDC Product Code
17856-1127
Application Number
M007
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
ORAL
Effective Date
May 23, 2025
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
Code: 1B5FPI42ENClass: ACTIBQuantity: 417.12 mg in 237 mL

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABEL 1

LABEL 2

LABEL 3


INDICATIONS & USAGE SECTION

Directions

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 yeart

l/2- 3/4teaspoon once a day

3/4 teaspoon twice a day

Children under 2 years

ask a doctor

ask a doctor


WARNINGS SECTION

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.


STORAGE AND HANDLING SECTION

Other Information

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

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

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

OTC - PURPOSE SECTION

Uses

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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


INACTIVE INGREDIENT SECTION

Inactive Ingredients

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


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