LEADER MAXIMUM STRENGTH LAXATIVE- calcium sennosides tablet

Leader Maximum Strength Laxative by

Drug Labeling and Warnings

Leader Maximum Strength Laxative by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each tablet)

 Calcium sennosides 25 mg

Purpose

 Stimulant laxative

Use(s)

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

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

• Swallow pill(s) with a glass of water
• Swallow pill(s) whole, do not crush, break or chew.

• adults and children 12 years and over: take 2 tablets once or twice daily with a glass of water
• children 6 to under 12 years: take 1 tablet once or twice daily with a glass of water
• children under 6 years: ask a doctor

Other information

• do not use if individual blister compartments are torn or open
• store at room temperature
• Calcium content: 40 mg per tablet
• Magnesium content: 10mg per tablet 

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

INGREDIENTS AND APPEARANCE

LEADER MAXIMUM STRENGTH LAXATIVE 
calcium sennosides tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-294
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN)	SENNOSIDES A AND B	25 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	BLUE	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	44;348
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-294-62	2 in 1 CARTON
1		12 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	03/01/2012

Labeler - Cardinal Health (097537435)