NATURAL SENNA - sennosides tablet 
Contract Pharmacal Corp

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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Natural Senna

Drug Facts

Active ingredient

(in each rounded tablet)

Sennosides from Senna Concentrate 8.6 mg

Purpose

Laxative

Uses

  • relieves occasional constipation (irregularity)
  • generally causes bowel movement in 6-12 hours

Warnings

Do not use

  • laxative products for longer than one week unless directed by a doctor

Ask a doctor before use if you have

  • stomach pain, nausea, or vomiting, noticed a sudden change in bowel habits that continue 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 care 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

  • preferable at bedtime
  • adults – two tablets: maximum of 4 tablets twice daily
  • children (6-12 years) one tablet: maximum 2 tablets twice daily

Other information

  • Store at room temperature, USP
  • Contains 20 mg of calcium
  • Side effects occur. You may report side effects to FDA at 1-800-FDA-1088 (Toll Free).

Inactive ingredient

Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil and Polyethylene Gycol

*This product is not manufactured or by Purdue Frederick, owner of the registered trademark Senokot®

Manufactured by:
Contract Pharmacal Corp.
135 Adams Avenue
Hauppauge, NY 11788 USA
www.cpc.com
  R11/09

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

f4a8921b-figure-01

NATURAL SENNA 
sennosides tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10267-1122
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES A AND B8.6 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
Product Characteristics
ColorBROWN (Mottled brown) Scoreno score
ShapeROUNDSize9mm
FlavorImprint Code 1122
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10267-1122-1100 in 1 BOTTLE
2NDC:10267-1122-41000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/24/2001
Labeler - Contract Pharmacal Corp (968334974)
Establishment
NameAddressID/FEIBusiness Operations
Contract Pharmacal Corp968334974MANUFACTURE

Revised: 1/2012
Document Id: f4a8921b-1b27-4768-887a-81bad872a378
Set id: 002621a1-0f13-4e92-856b-5a850a48193e
Version: 3
Effective Time: 20120120
 
Contract Pharmacal Corp