CHOCOLATED LAXATIVE  REGULAR STRENGTH SENNOSIDES STIMULANT LAXATIVE TOPCARE HEALTH - sennosides tablet, chewable 
Topco Associates

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient (in each piece of 12 piece block)

Sennosides, USP, 15 mg

Purpose

Stimulant laxative

Uses

Warnings

Do not use laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor

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.

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 breastfeeding, 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.

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

Inactive ingredients

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

Questions or comments?

1-888-423-0139

Principal Display Panel - 15 mg Carton Label

NDC 36800-994-01

+TopCare®
health™

COMPARE TO EX-LAX®
ACTIVE INGREDIENT*

REGULAR STRENGTH
Chocolated
Laxative

SENNOSIDES, USP, 15 mg

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24 PIECECS

actual size

Principal Display Panel - 15 mg Carton Label
CHOCOLATED LAXATIVE   REGULAR STRENGTH SENNOSIDES STIMULANT LAXATIVE TOPCARE HEALTH
sennosides tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-994
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sennosides (UNII: 3FYP5M0IJX) (Sennosides - UNII:3FYP5M0IJX) Sennosides15 mg
Inactive Ingredients
Ingredient NameStrength
cocoa (UNII: D9108TZ9KG)  
cotton seed (UNII: DI0ZRJ0MXN)  
palm kernel oil (UNII: B0S90M0233)  
sodium chloride (UNII: 451W47IQ8X)  
lecithin, soybean (UNII: 1DI56QDM62)  
sucrose (UNII: C151H8M554)  
vanilla (UNII: Q74T35078H)  
whey (UNII: 8617Z5FMF6)  
Product Characteristics
Colorbrown (brown) Scoreno score
ShapeRECTANGLE (RECTANGLE) Size9mm
FlavorImprint Code CL
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-994-012 in 1 CARTON03/26/2021
112 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/26/2021
Labeler - Topco Associates (006935977)
Registrant - Aphena Pharma Solutions MD, LLC (829739833)
Establishment
NameAddressID/FEIBusiness Operations
Aphena Pharma Solutions MD, LLC829739833MANUFACTURE(36800-994)

Revised: 2/2023
Document Id: d4716e40-b7fc-445f-8cb5-70e9a98f876a
Set id: f051b302-f70e-4ab6-bb69-f69b45f2642e
Version: 2
Effective Time: 20230213
 
Topco Associates