LAXATIVE PILLS MAXIMUM STRENGTH- sennosides tablet 
TOP CARE (Topco Associates LLC)

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 tablet)

Sennosides 25 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 a prescription 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 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.

Directions

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

Other information

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, sucrose, talc, titanium dioxide


Questions or comments?

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Principal Display Panel

COMPARE TO EX-LAX® MAXIMUM STRENGTH ACTIVE INGREDIENT†

MAXIMUM STRENGTH

LAXATIVE

SENNOSIDES USP,  25 mg • STIMULANT LAXATIVE 

TABLETS

This product is not manufactured or distributed by GlaxoSmithKline 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 TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

topcare@topco.com

www.topcarebrand.com

Product Label

Sennosides USP, 25 mg

TOPCARE HEALTH Maximum Strength Laxative

LAXATIVE PILLS  MAXIMUM STRENGTH
sennosides tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-492
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES25 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
Product Characteristics
ColorblueScoreno score
ShapeROUNDSize11mm
FlavorImprint Code TCL083;S25
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-492-2424 in 1 CARTON06/30/2016
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33406/30/2016
Labeler - TOP CARE (Topco Associates LLC) (006935977)

Revised: 12/2022
Document Id: 63df38f5-de50-4541-9da4-e066da4a6783
Set id: 25b22930-ca33-48e1-970e-788452e78292
Version: 4
Effective Time: 20221219
 
TOP CARE (Topco Associates LLC)