SPL v1
SPL
SPL Set ID 80780753-780d-4de8-b769-0e89809615fe
Route
ORAL
Published
Effective Date 2025-08-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides (15 mg)
Inactive Ingredients
Acacia Calcium Carbonate Carnauba Wax Starch, Corn Dibasic Calcium Phosphate Dihydrate Ferrosoferric Oxide Ferric Oxide Red Ferric Oxide Yellow Magnesium Stearate Methylparaben Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Povidone, Unspecified Propylene Glycol Propylparaben Shellac Silicon Dioxide Sodium Benzoate Sodium Lauryl Sulfate Sucrose Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;347 Shape: round Color: brown Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-01

Description

Sennosides 15 mg

Purpose

Stimulant Laxative


Medication Information

Purpose

Stimulant Laxative

Description

Sennosides 15 mg

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 12 hours
Directions
  • swallow tablets with a glass of water
  • swallow tablets whole; do not crush, break, or chew
adults and children 12 years of age and older Take 2 tablets once or twice daily
children 6 to under 12 years of age Take 1 tablet once or twice daily
children under 6 years of age Ask a doctor

Do Not Use

laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor.

Questions?

call toll-freee 1-844-912-4012

Other Information
  • TAMPER EVIDENT: DO NOT USE IF SEAL AROUND TABLET IS BROKEN OR DAMAGED
  • each tablet contains:calcium 35 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients

acacia, calcium carbonate, carnauba wax, corn starch, dicalcium phosphate, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, maltodextrin**, methylparaben, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, propylparaben, shellac, silica gel, sodium benzoate, sodium lauryl sulfate, sucrose, talc, titanium dioxide.       **may contain this ingredient

Principal Display Panel

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 bindicate a serious condition.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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

Active Ingredient (in Each Tablet)

Sennosides 15 mg

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.


Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 12 hours
Purpose

Stimulant Laxative

Directions
  • swallow tablets with a glass of water
  • swallow tablets whole; do not crush, break, or chew
adults and children 12 years of age and older Take 2 tablets once or twice daily
children 6 to under 12 years of age Take 1 tablet once or twice daily
children under 6 years of age Ask a doctor

Do Not Use (Do not use)

laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor.

Questions?

call toll-freee 1-844-912-4012

Other Information (Other information)
  • TAMPER EVIDENT: DO NOT USE IF SEAL AROUND TABLET IS BROKEN OR DAMAGED
  • each tablet contains:calcium 35 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients (Inactive ingredients)

acacia, calcium carbonate, carnauba wax, corn starch, dicalcium phosphate, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, maltodextrin**, methylparaben, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, propylparaben, shellac, silica gel, sodium benzoate, sodium lauryl sulfate, sucrose, talc, titanium dioxide.       **may contain this ingredient

Principal Display Panel (Principal display panel)

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 bindicate a serious condition.

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

ask a health professional before use.

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

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

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Sennosides 15 mg

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.


Advanced Ingredient Data


Raw Label Data

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