3052C-Cardinal

Drug Labeling and Warnings

Drug Details [pdf]

SENNOSIDES, DOCUSATE SODIUM- sennosides, docusate sodium tablet, film coated 
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.

----------

3052C-Cardinal

Drug Facts

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Purposes

Stool softener

Stimulant laxative

Uses

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

Do not use

• laxative products for longer than 1 week unless directed by a doctor
• if you are now taking mineral oil, unless directed by a doctor

Ask a doctor before use if you have

• stomach pain 
• nausea 
• vomiting
• noticed a sudden change in bowel habits that lasts over a period of 2 weeks

Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate 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 (1-800-222-1222) right away.

Directions

• take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.

• adults and children 12 years and older:

  take 2-4

  tablets daily

• children 6 to under 12 years of age:

  take 1-2

  tablets daily

• children 2 to under 6 years of age:

  take up to 1

  tablet daily

• children under 2 years:

  ask a doctor

Other information

• each tablet contains: calcium 11 mg
• each tablet contains: sodium 4 mg
• store at 25°C (77°F); excursions permitted between 15º-30ºC (59º-86ºF)

croscarmellose sodium, dicalcium phosphate, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #6 lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacetin

Questions or comments?

Call 1-800-231-4670

Do not use if product appears to be tampered with or seal is broken.

†This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace®2-IN-1.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

100% Money Back Guarantee

Return to place of purchase if not satisfied.

© 2018 Cardinal Health. All Rights Reserved. CARDINAL HEALTH,

the Cardinal Health LOGO, LEADER, and the Leader LOGO are

trademarks or registered trademarks of Cardinal Health.

LEADER TM

NDC: 70000-0403-1

Stool Softner+ Stimulant Laxative

Docusate Sodium, 50 mg

Sennosides, 8.6, mg

COMPARE TO COLACE® 2-IN-1† active ingredients

100 Tablets

SENNOSIDES, DOCUSATE SODIUM 
sennosides, docusate sodium tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0403
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	8.6 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg

Inactive Ingredients
Ingredient Name	Strength
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
TRIACETIN (UNII: XHX3C3X673)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	CPC;490
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0403-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/10/2019	01/10/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	01/10/2019	01/10/2019

Labeler - Cardinal Health (097537435)

Revised: 10/2019

Document Id: 9521f65d-8918-3fd4-e053-2a95a90a858f

34390-5

Set id: 7c4b0aef-6efe-4bde-e053-2991aa0a401f

Version: 2

Effective Time: 20191017