SENNAGEN- sennosides tablet, coated 
Goldline Laboratories, Inc.

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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SennaGen
NDC 0182-1093-01
100 TABLETS 1211REV

TAMPER-EVIDENT: Do not use this product if imprinted foil seal over the mouth of the bottle is cut, torn, broken or missing.

Drug Facts

Active ingredient (in each tablet)

Sennosides 8.6 mg

Purpose

Laxative

Uses

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

Warnings

Do not use laxative products for more than 1 week unless directed by a doctor

Ask a doctor before use if you have

  • nausea
  • stomach pain
  • vomiting
  • noticed a sudden change in bowel movements that continues 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 right away.

Directions

  • take preferably at bedtime or as directed by a doctor
  • if you do not have a comfortable bowel movement by the second day, increase dose by 1 tablet (do not exceed maximum dosage) or decrease dose until you are comfortable
agestarting dosagemaximum dosage
adults and children 12 years and over2 tablets once a day4 tablets twice a day
children 6 to under 12 years1 tablet once a day2 tablets twice a day
children 2 to under 6 years½ tablet once a day1 tablet twice a day
children under 2 yearsask a doctorask a doctor

Other information

  • each tablet contains: calcium 25 mg, sodium 2 mg (VERY LOW SODIUM)
  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)

Inactive ingredients

croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil

Questions?

call 1-888-838-2872, weekdays, 8 AM-5 PM Eastern Time

*This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot®.

Distributed by:
GOLDLINE LABORATORIES, INC.
Sellersville, PA 18960
1211REV 89 191R

PRINCIPAL DISPLAY PANEL - 8.6 mg Label

SennaGen Tablets 100s Label

SennaGen Tablets 100s Label Text

Goldline®

NDC 0182-1093-01
TAMPER-EVIDENT

SennaGen

(brand of standarized
senna concentrate
equivalent to 8.6 mg
sennosides per tablet)

Natural Vegetable
Stimulant Laxative

100 TABLETS

Compare to the active ingredient
of Senokot® Tablets*

SENNAGEN 
sennosides tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0182-1093
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 B8.6 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
Product Characteristics
ColorBROWNScoreno score
ShapeROUND (biconvex) Size9mm
FlavorImprint Code TCL;080
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0182-1093-01100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/01/200012/31/2016
Labeler - Goldline Laboratories, Inc. (032349292)

Revised: 7/2014
Document Id: 182c80dd-f19b-462c-9b9a-ff2d03de17c8
Set id: dcdb7856-c6d4-4ed5-b0f1-3e6797c7aa77
Version: 4
Effective Time: 20140708
 
Goldline Laboratories, Inc.