drug facts

drug facts
SPL v5
SPL
SPL Set ID e80be2b6-a0ca-4838-b956-a1debb065d57
Route
oral
Published
Effective Date 2014-03-12
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 completed Since 2014-01-01 Until 2027-09-30

Purpose

Stimulant laxative

Description

Sennosides, USP, 15 mg


Medication Information

Warnings

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

Stimulant laxative

Directions

​​​

adults and children 12 years of age and older
  • chew 2 chocolated pieces once or twice daily
children 6 to under 12 years of age
  • chew 1 chocolated 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 15o- 25oC (59o- 77oF)
Inactive Ingredients

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

Description

Sennosides, USP, 15 mg

Do Not Use

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

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.

Ask A Doctor Before Use If You Have
  • noticed a sudden change in bowel habits that persists over a period of 2 weeks
Questions Or Comments? 248 449 9300

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.
Active Ingredient (in Each Piece of 12 Piece Block)

Sennosides, USP, 15 mg

Principal Display Panel 15 Mg Chewable Tablet Carton

QC®

Quality Choice

NDC 63868-266-24

Regular Strength

Chocolated Laxative

Relieves Occasional Constipation

Sennosides, USP, 15 mg | Stimulant Laxative

  • Relief of Occasional Constipation
  • Chocolate Flavored

*Compare to active ingredient in ex-lax®

Satisfaction Guaranteed

24 pieces

Made in the USA

Distributed by C.D.M.A., Inc.

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Questions: 248-449-9300


Structured Label Content

Warnings

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

Stimulant laxative

Directions

​​​

adults and children 12 years of age and older
  • chew 2 chocolated pieces once or twice daily
children 6 to under 12 years of age
  • chew 1 chocolated 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 15o- 25oC (59o- 77oF)
Inactive Ingredients

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

Do Not Use (Do not use)

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

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.

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
Questions Or Comments? 248 449 9300 (Questions or comments? 248-449-9300)

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

Sennosides, USP, 15 mg

Principal Display Panel 15 Mg Chewable Tablet Carton (PRINCIPAL DISPLAY PANEL - 15 mg CHEWABLE TABLET CARTON)

QC®

Quality Choice

NDC 63868-266-24

Regular Strength

Chocolated Laxative

Relieves Occasional Constipation

Sennosides, USP, 15 mg | Stimulant Laxative

  • Relief of Occasional Constipation
  • Chocolate Flavored

*Compare to active ingredient in ex-lax®

Satisfaction Guaranteed

24 pieces

Made in the USA

Distributed by C.D.M.A., Inc.

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Questions: 248-449-9300


Advanced Ingredient Data


Raw Label Data

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