Onelax Senna Syrup

Onelax Senna Syrup
SPL v1
SPL
SPL Set ID 40202c76-4273-88fd-e063-6394a90a07b2
Route
ORAL
Published
Effective Date 2024-02-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides A And B (417.12 mg)
Inactive Ingredients
Methylparaben Propylene Glycol Propylparaben Water Sucrose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-06

Description

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


Medication Information

Dosage and 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 1/2teaspoons 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

Description

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

Section 51945-4

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

Directions

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

Active Ingredient

Active ingredient(in each teaspoonful)          Purpose

Sennosides 8.8 mg …………………………................Laxative

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

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.

Keep Out of Reach of Children

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

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children Section

In case of accidental overdose, get medical help immediately or contact Poison Control Center immediately 1(800) 222-1222

To Report Adverse Drug Event contact the FDA at 1-800- FDA-1088 or www.fda.gov/medwatch.

Questions?

Call 1(800) 509-7592

Distributed By:

Atlaantic Biologicals Corp.

Miami, FL 33179

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.


Structured Label Content

Uses

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

Dosage and Administration (34068-7)
 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

Section 51945-4 (51945-4)

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

Directions

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

Active Ingredient

Active ingredient(in each teaspoonful)          Purpose

Sennosides 8.8 mg …………………………................Laxative

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

Stop Use and Ask A Doctor If (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.

Keep Out of Reach of Children (Keep out of reach of children)

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

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children Section (KEEP OUT OF REACH OF CHILDREN SECTION)

In case of accidental overdose, get medical help immediately or contact Poison Control Center immediately 1(800) 222-1222

To Report Adverse Drug Event contact the FDA at 1-800- FDA-1088 or www.fda.gov/medwatch.

Questions?

Call 1(800) 509-7592

Distributed By:

Atlaantic Biologicals Corp.

Miami, FL 33179

Ask A Doctor Or Pharmacist Before Use If (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.


Advanced Ingredient Data


Raw Label Data

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