LEADER MAXIMUM STRENGTH LAXATIVE- calcium sennosides tablet 
Cardinal Health

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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Leader Maximum Strength Laxative

Active ingredients (in each tablet)

 Calcium sennosides 25 mg

Purpose

 Stimulant laxative

Use(s)

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 immediately.

Directions

adults and children 12 years and overtake 2 tablets once or twice daily with a glass of water
children 6 to under 12 yearstake 1 tablet once or twice daily with a glass of water
children under 6 yearsask a doctor 

Other information

Inactive ingredients

acacia, anhydrous lactose, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C Blue #1 aluminum lake, iron oxide, iron oxide black, iron oxide yellow, kaolin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, shellac, sodium lauryl sulfate, stearic acid, sugar, talc, tartaric acid, titanium dioxide.

Principal Display Panel

LEADER®

Compare to the EX-LAX® Maximum Strength Tablets active ingredient*

Maximum Strength

Laxative

Laxative Stimulant

calcium sennosides, 25mg

Gentle, dependable overnight relief of constipation

24 TABLETS

Distributed By: Cardinal Health

Dublin, Ohio 43017

www.myleader.com

CIN 2740934

Leader Maximum Strength Laxative

LEADER MAXIMUM STRENGTH LAXATIVE 
calcium sennosides tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-294
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) SENNOSIDES A AND B25 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FERROUS OXIDE (UNII: G7036X8B5H)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
POVIDONE (UNII: FZ989GH94E)  
SHELLAC (UNII: 46N107B71O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBLUEScoreno score
ShapeROUNDSize11mm
FlavorImprint Code 44;348
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-294-622 in 1 CARTON
112 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/01/2012
Labeler - Cardinal Health (097537435)

Revised: 3/2012
Document Id: d2574c2c-a7d2-45f1-9eb4-ac0f315febc8
Set id: d2574c2c-a7d2-45f1-9eb4-ac0f315febc8
Version: 1
Effective Time: 20120315
 
Cardinal Health