Sennosides Usp 25 Mg Tablets

Sennosides Usp 25 Mg Tablets
SPL v4
SPL
SPL Set ID 7cae52ae-931c-3e7c-e053-2991aa0a8396
Route
ORAL
Published
Effective Date 2019-04-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides (25 mg)
Inactive Ingredients
Dibasic Calcium Phosphate Dihydrate Kaolin Magnesium Stearate Maltodextrin Polyethylene Glycol 400 Raw Sugar Croscarmellose Fd&c Blue No. 1 Stearic Acid Microcrystalline Cellulose Starch, Corn Povidone Shellac Ferric Oxide Yellow Ferrosoferric Oxide Calcium Cation Titanium Dioxide Carnauba Wax Talc Acacia

Identifiers & Packaging

Pill Appearance
Imprint: TCL083 Shape: round Color: blue Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-04-09

Description

Sennosides USP, 25 mg

Purpose

Stimulant laxative


Medication Information

Warnings and Precautions

Warnings

Purpose

Stimulant laxative

Description

Sennosides USP, 25 mg

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

Section 51945-4

Directions
  • swallow tablet (s) with a glass of water.
  • swallow tablet (s) whole, do not crush, break or chew.

adults and children 12 years of age and older: 2 tablets once or twice daily

children 6 to under 12 years of age: 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

Other Information
  • each tablet contains: calcium 40 mg, sodium 2 mg (VERY LOW SODIUM)
  • store between 20°-25°C (68°-77°F)
Inactive Ingredients

acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, iron oxide, iron oxide black, iron oxide yellow, kaolin, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, shellac, stearic acid, sugar, talc, titanium dioxide.

Questions Or Comments?

Call 1-800-910-6874

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.

Keep Out of Reach of Children

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

If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredient (in Each Tablet)

Sennosides USP, 25 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

Warnings and Precautions (34071-1)

Warnings

Section 51945-4 (51945-4)

Purpose

Stimulant laxative

Directions
  • swallow tablet (s) with a glass of water.
  • swallow tablet (s) whole, do not crush, break or chew.

adults and children 12 years of age and older: 2 tablets once or twice daily

children 6 to under 12 years of age: 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

Other Information (Other information)
  • each tablet contains: calcium 40 mg, sodium 2 mg (VERY LOW SODIUM)
  • store between 20°-25°C (68°-77°F)
Inactive Ingredients (Inactive ingredients)

acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, iron oxide, iron oxide black, iron oxide yellow, kaolin, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, shellac, stearic acid, sugar, talc, titanium dioxide.

Questions Or Comments? (Questions or comments?)

Call 1-800-910-6874

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.

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 (1-800-222-1222).

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

ask a health professional before use.

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

Sennosides USP, 25 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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