Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 56d6876f-6415-42e3-9a8f-08e99b1e7042
Route
ORAL
Published
Effective Date 2023-10-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: TCL083 Shape: round Color: blue Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-08-31

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
QUALITY CHOICE Maximum Strength Laxative
Other Information
  • each tablet contains: calcium 40 mg
  • very low sodium
  • store between 20-25ºC (68-77ºF)
Inactive Ingredients

acacia, calcium phosphate dihydrate, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, 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 1-248-449-9300 Monday-Friday 9AM-5PM EST

Principal Display Panel

*Compare to the active ingredient in ex-lax® MAXIMUM STRENGTH

Maximum Strength

Laxative

Stimulant Laxative

Sennosides USP, 25 mg

Gentle, Dependable Overnight Relief

Tablets

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

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by C.D.M.A., Inc.©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

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.

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 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 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
QUALITY CHOICE Maximum Strength Laxative
Other Information (Other information)
  • each tablet contains: calcium 40 mg
  • very low sodium
  • store between 20-25ºC (68-77ºF)
Inactive Ingredients (Inactive ingredients)

acacia, calcium phosphate dihydrate, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, 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 1-248-449-9300 Monday-Friday 9AM-5PM EST

Principal Display Panel

*Compare to the active ingredient in ex-lax® MAXIMUM STRENGTH

Maximum Strength

Laxative

Stimulant Laxative

Sennosides USP, 25 mg

Gentle, Dependable Overnight Relief

Tablets

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

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by C.D.M.A., Inc.©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

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.

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 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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