Onelax Senna Syrup
FDA Label NDC 17856-1127

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Atlantic Biologicals Corp. for the product Onelax Senna (NDC 17856-1127). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, uses, warnings, ask a doctor or pharmacist before use if, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

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

Uses

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

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.

Directions

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

Dosage & Administration

 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 1/2 teaspoons once a day 11/2 teaspoons twice a day
 Children 2 years to under 6 yeartl/2 - 3/4 teaspoon once a day 3/4 teaspoon twice a day
 Children under 2 years ask a doctor ask a doctor

Other Information

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

Inactive Ingredients

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

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

* Please review the disclaimer below.