Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 10dc8b4d-8136-44a5-a2ce-30295866cd3b
Route
ORAL
Published
Effective Date 2024-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides (15 mg)
Inactive Ingredients
Cocoa Cotton Seed Palm Kernel Oil Sodium Chloride Lecithin, Soybean Sucrose Vanilla Whey

Identifiers & Packaging

Pill Appearance
Imprint: CL Shape: rectangle Color: brown Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-02-23

Description

Sennosides, USP, 15 mg

Purpose

Stimulant laxative


Medication Information

Purpose

Stimulant laxative

Description

Sennosides, USP, 15 mg

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 12 hours
Section 50565-1

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

Section 50570-1

Do not use laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use.

Directions
adults and children 12 years of age and older chew 2 chocolate pieces once or twice daily
children 6 to under 12 years of age chew 1 chocolate piece once or twice daily
children under 6 years of age ask a doctor
Other Information
  • each piece contains: potassium 5 mg
  • contains milk and soy ingredients
  • gluten-free
  • store at 15°-25°C (59°-77°F)
Inactive Ingredients

cocoa powder, hydrogenated vegetable oils (palm, palm kernel), salt, soy lecithin (an emulsifier), sugar, vanilla, and whey powder (milk)

Questions Or Comments?

1-888-287-1915

When Using This Product
  • do not use for a period longer than 1 week
Stop Use and Ask A Doctor If
  • rectal bleeding or failure to have a bowel movement occur after use of a laxative. These may be signs of a serious condition.
Ask A Doctor Before Use If You Have
  • noticed a sudden change in bowel habits that persists over a period of 2 weeks
Ask A Doctor Or Pharmacist Before Use If You
  • are taking any other drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs.
Principal Display Panel 15 Mg Carton Label

equate

NDC 49035-349-24

Compare

to ex-lax®

active

ingredient*

REGULAR STRENGTH

Chocolate Laxative

Sennosides, USP, 15 mg

Stimulant Laxative

  • Relieves occasional constipation
  • Chocolate flavored

Actual Size

15

mg

24

PIECES

Active Ingredient (in Each Piece of 12 Piece Block)

Sennosides, USP, 15 mg


Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 12 hours
Section 50565-1 (50565-1)

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

Section 50570-1 (50570-1)

Do not use laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use.

Purpose

Stimulant laxative

Directions
adults and children 12 years of age and older chew 2 chocolate pieces once or twice daily
children 6 to under 12 years of age chew 1 chocolate piece once or twice daily
children under 6 years of age ask a doctor
Other Information (Other information)
  • each piece contains: potassium 5 mg
  • contains milk and soy ingredients
  • gluten-free
  • store at 15°-25°C (59°-77°F)
Inactive Ingredients (Inactive ingredients)

cocoa powder, hydrogenated vegetable oils (palm, palm kernel), salt, soy lecithin (an emulsifier), sugar, vanilla, and whey powder (milk)

Questions Or Comments? (Questions or comments?)

1-888-287-1915

When Using This Product (When using this product)
  • do not use for a period longer than 1 week
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rectal bleeding or failure to have a bowel movement occur after use of a laxative. These may be signs of a serious condition.
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • noticed a sudden change in bowel habits that persists over a period of 2 weeks
Ask A Doctor Or Pharmacist Before Use If You (Ask a doctor or pharmacist before use if you)
  • are taking any other drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs.
Principal Display Panel 15 Mg Carton Label (Principal Display Panel - 15 mg Carton Label)

equate

NDC 49035-349-24

Compare

to ex-lax®

active

ingredient*

REGULAR STRENGTH

Chocolate Laxative

Sennosides, USP, 15 mg

Stimulant Laxative

  • Relieves occasional constipation
  • Chocolate flavored

Actual Size

15

mg

24

PIECES

Active Ingredient (in Each Piece of 12 Piece Block) (Active ingredient (in each piece of 12 piece block))

Sennosides, USP, 15 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)