Assured 44-298-Delisting

Drug Labeling and Warnings

Drug Details [pdf]

NATURAL LAXATIVE- sennosides tablet, film coated 
GREENBRIER INTERNATIONAL, 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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Assured 44-298-Delisting

Active ingredient
(in each tablet)

Sennosides USP, 8.6 mg

Purpose

Laxative

Uses

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

Warnings

Do not use

laxative products for longer than 1 week 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 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 (1-800-222-1222) right away.

Directions

  • take preferably at bedtime or as directed by a doctor

agestarting
dosage 		maximum
dosage 
adults and
children 12
years and
over		2 tablets
once a day		4 tablets
twice a
day 
children 6 to
under 12
years		1 tablet once
a day 		2 tablets
twice a
day 
children 2 to
under 6 years		1/2 tablet
once a day 		1 tablet
twice a
day 
children under
2 years		ask a
doctor 		ask a
doctor 

Other information

  • each tablet contains: calcium 27 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from moisture
  • see end flap for expiration date and lot number

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, silica gel

Questions or comments?

1-800-426-9391

Principal Display Panel

COMPARE TO ACTIVE INGREDIENT OF
SENOKOT®*

Natural Laxative

Sennosides USP, 8.6 mg
   Laxative

Gentle, Overnight Relief
Natural Vegetable Laxative Ingredient

50 tablets

TAMPER EVIDENT: DO NOT USE IF
IMPRINTED SAFETY SEAL UNDER CAP
IS BROKEN OR MISSING

50844     ORG091429815

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

item #229925

Distributed by GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY, CHESAPEAKE, VA 23320
ASSURED 44-298

ASSURED 44-298

NATURAL LAXATIVE 
sennosides tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 33992-0298
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorBROWN (greenish) Scoreno score
ShapeROUNDSize9mm
FlavorImprint Code 44;298
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 33992-0298-51 in 1 CARTON01/27/199507/08/2019
150 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33401/27/199507/08/2019
Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(33992-0298)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(33992-0298)

Revised: 7/2016
Document Id: 0720a50c-7d05-43e1-a7ff-0703ed649a04
Set id: 4be54c44-afe7-46a6-b420-834982bb5fb5
Version: 2
Effective Time: 20160726