Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 14ad727a-ec46-4570-9887-e8bfa7567f58
Route
ORAL
Published
Effective Date 2022-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides (25 mg)
Inactive Ingredients
Acacia Ammonia Calcium Carbonate Calcium Phosphate, Dibasic, Dihydrate Calcium Sulfate Anhydrous Carnauba Wax Starch, Corn Croscarmellose Sodium Calcium Phosphate, Dibasic, Anhydrous Fd&c Blue No. 1 Aluminum Oxide Hypromelloses Ferric Oxide Red Ferrosoferric Oxide Ferric Oxide Yellow Isopropyl Alcohol Kaolin Magnesium Stearate Cellulose, Microcrystalline Butyl Alcohol Polyethylene Glycol, Unspecified Povidone Propylene Glycol Shellac Silicon Dioxide Sodium Lauryl Sulfate Stearic Acid Sucrose Talc Titanium Dioxide White Wax Maltodextrin Mineral Oil Polyvinyl Alcohol, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: TCL083;S25 Shape: round Color: blue Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-07-31

Description

Sennosides USP, 25 mg

Purpose

Stimulant laxative


Medication Information

Purpose

Stimulant laxative

Description

Sennosides USP, 25 mg

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

Product Label
GOODSENSE Laxative Pills
Other Information
  • each tablet contains: calcium 50 mg
  • very low sodium 
  • store between 20-25ºC (68-77ºF)  
Inactive Ingredients

acacia, ammonium hydroxide*, calcium carbonate*, calcium phosphate dihydrate*, calcium sulfate anhydrous*, carnauba wax, corn starch*, croscarmellose sodium, dicalcium phosphate*, FD&C blue #1 aluminum lake, hypromellose*, iron oxide*, iron oxide black, iron oxide yellow*, isopropyl alcohol*, kaolin*, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, n-butyl alcohol*, polyethylene glycol, polyvinyl alcohol*, povidone*, propylene glycol*, shellac, silicon dioxide*, sodium lauryl sulfate*,  stearic acid*, sucrose, talc, titanium dioxide, white wax*

*contains one or more of these ingredients

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Maximum Strength

Laxative pills 

Sennosides USP, 25 mg

Stimulant Laxative

  • Specialists In Gentle, Dependable Overnight Relief

PILLS

**Compare to active ingredient in ex-lax® Maximum Strength

**This product is not manufactured or distributed by GlaxoSmithKline plc, distributor of Ex-Lax®.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by:

Geiss, Destin & Dunn, Inc.

Peachtree City, GA 30269

www.valuelabels.com

When Using This Producct
  • 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.

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.

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 a prescription 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 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  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.

Product Label
GOODSENSE Laxative Pills
Other Information (Other information)
  • each tablet contains: calcium 50 mg
  • very low sodium 
  • store between 20-25ºC (68-77ºF)  
Inactive Ingredients (Inactive ingredients)

acacia, ammonium hydroxide*, calcium carbonate*, calcium phosphate dihydrate*, calcium sulfate anhydrous*, carnauba wax, corn starch*, croscarmellose sodium, dicalcium phosphate*, FD&C blue #1 aluminum lake, hypromellose*, iron oxide*, iron oxide black, iron oxide yellow*, isopropyl alcohol*, kaolin*, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, n-butyl alcohol*, polyethylene glycol, polyvinyl alcohol*, povidone*, propylene glycol*, shellac, silicon dioxide*, sodium lauryl sulfate*,  stearic acid*, sucrose, talc, titanium dioxide, white wax*

*contains one or more of these ingredients

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Maximum Strength

Laxative pills 

Sennosides USP, 25 mg

Stimulant Laxative

  • Specialists In Gentle, Dependable Overnight Relief

PILLS

**Compare to active ingredient in ex-lax® Maximum Strength

**This product is not manufactured or distributed by GlaxoSmithKline plc, distributor of Ex-Lax®.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by:

Geiss, Destin & Dunn, Inc.

Peachtree City, GA 30269

www.valuelabels.com

When Using This Producct (When using this producct)
  • 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.

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

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 a prescription 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

All Sections (JSON)