FDA.reportPublic FDA data

Chocolated Laxative

Manufacturer
C.D.M.A., Inc. | Aphena Pharma Solutions MD, LLC
Effective date
2024-12-23
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:48:44

Label at a glance#

ProductChocolated Laxative
Active ingredientSennosides
Label structure14 sections

Indications and uses

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

Dosage and administration

​​​ 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

Storage and handling

​each piece contains: ​potassium 5 mg contains milk and soy ingredients gluten free store at 15 o - 25 o C (59 o - 77 o F)

Label contents#

Full prescribing information#

Active ingredient (in each piece of 12 piece block)

OTC - ACTIVE INGREDIENT SECTION

Sennosides, USP, 15 mg

Purpose

OTC - PURPOSE SECTION

Stimulant laxative

Uses

INDICATIONS & USAGE SECTION

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

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR/PHARMACIST SECTION

  • noticed a sudden change in bowel habits that persists over a period of 2 weeks

Ask a doctor or pharmacist before use if you

OTC - ASK DOCTOR/PHARMACIST SECTION

  • are taking any other drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs.

When using this product

OTC - WHEN USING SECTION

  • do not use for a period longer than 1 week

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

​​​

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

STORAGE AND HANDLING SECTION

  • ​each piece contains: ​potassium 5 mg
  • contains milk and soy ingredients
  • gluten free
  • store at 15o- 25oC (59o- 77oF)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

PRINCIPAL DISPLAY PANEL - 15 mg CHEWABLE TABLET CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

​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

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
251020sennosides 15 MG Chewable TabletPSN5
251020sennosides, USP 15 MG Chewable TabletSCD5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-266-242023-02-09C16284748780-1ba0f9c33-2df0-a910-e053-dadaa90a0b85Drug Facts
63868-266-242023-01-30C16284748780-1ba0f9c33-2df0-a910-e053-dadaa90a0b85Drug Facts
63868-266-242021-03-23C16284748780-1ba0f9c33-2df0-a910-e053-dadaa90a0b85Drug Facts
63868-266-242021-01-29C16284748780-1ba0f9c33-2df0-a910-e053-dadaa90a0b85Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-266-24Chocolated Laxative2 in 1 CARTONTABLET, CHEWABLE25
63868-266-24Chocolated Laxative12 in 1 POUCHTABLET, CHEWABLE125

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-266CHOCOLATED LAXATIVE (SENNOSIDES STIMULANT LAXATIVE) TABLET, CHEWABLE [C.D.M.A., INC.]5Current NDC, Legacy NDC, 2 package rows20241226_e80be2b6-a0ca-4838-b956-a1debb065d57.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-266-24EA - Each63868-2667cfae5c9-06f7-4175-8a2e-b039e66a07b912022-07-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SENNOSIDESACTIVE INGREDIENT3FYP5M0IJX1
SENNOSIDESACTIVE MOIETY3FYP5M0IJX1
COCOAINACTIVE INGREDIENTD9108TZ9KG1
COTTON SEEDINACTIVE INGREDIENTDI0ZRJ0MXN1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM621
PALM KERNEL OILINACTIVE INGREDIENTB0S90M02331
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X1
SUCROSEINACTIVE INGREDIENTC151H8M5541
VANILLAINACTIVE INGREDIENTQ74T35078H1
WHEYINACTIVE INGREDIENT8617Z5FMF61

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-26663868-266-24

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
Sennosides3FYP5M0IJXACTIB
cocoaD9108TZ9KGIACT
cotton seedDI0ZRJ0MXNIACT
palm kernel oilB0S90M0233IACT
sodium chloride451W47IQ8XIACT
lecithin, soybean1DI56QDM62IACT
sucroseC151H8M554IACT
vanillaQ74T35078HIACT
whey8617Z5FMF6IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 16 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62TABLET / ORAL8 mgExact identifier — unii+route
10 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62TABLET, EXTENDED RELEASE / ORAL20 mgExact identifier — unii+route
10 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62TABLET / ORAL8 mgExact identifier — unii+route
10 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62TABLET, FILM COATED / ORAL0.33 mgExact identifier — unii+route
10 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, CHEWABLE / ORAL20 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, CHEWABLE / ORAL7258 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62CAPSULE / ORAL20 mgExact identifier — unii+route
10 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62POWDER, FOR SUSPENSION / ORAL39 mgExact identifier — unii+route
10 equally ranked IID candidates
COCOACOCOAD9108TZ9KGSUSPENSION / ORAL246.66 mg/5mlExact identifier — unii+route
2 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, CHEWABLE / ORAL7258 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62CAPSULE / ORAL20 mgExact identifier — unii+route
10 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, CHEWABLE / ORAL20 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
COCOACOCOAD9108TZ9KGSUSPENSION / ORAL246.66 mg/5mlExact identifier — unii+route
2 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62POWDER, FOR SUSPENSION / ORAL39 mgExact identifier — unii+route
10 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62TABLET, FILM COATED / ORAL0.33 mgExact identifier — unii+route
10 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62TABLET, EXTENDED RELEASE / ORAL20 mgExact identifier — unii+route
10 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chocolated LaxativeSENNOSIDES STIMULANT LAXATIVEC.D.M.A., Inc.e80be2b6-a0ca-4838-b956-a1debb065d572024-12-23WarningsExact identifier
ndc (package): 63868-266-24
ndc (product): 63868-266
ndc11 (package): 63868026624
spl id: ee728b2c-73f2-4c8b-9a78-eddb67229d9f
spl set id: e80be2b6-a0ca-4838-b956-a1debb065d57

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.