Senna Gen

Dosage form: tablet
Ingredients: SENNOSIDES 8.6mg
Labeler: Cardinal Health
NDC Code: 55154-6163

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Senna-Gen Tablets

Active ingredient

In each tablet: Sennosides 8.6 mg

Purpose

Laxative

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Uses

Relieves occasional constipation (irregularity); generally causes a bowel movement in 6 to 12 hours.

Warnings

If pregnant or breast-feeding, ask a health professional before use.

This package is intended for institutional use only. This unit dose package is not child-resistant. If dispensed for outpatient use, a child-resistant container should be utilized.

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

Ask a doctor before use if you have stomach pain, nausea, vomiting or have noticed a sudden change in bowel habits that persists 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 could be signs of a serious condition.

TAMPER-EVIDENT: Each tablet is individually sealed. Do not use if blister or foil is broken, torn, or missing.

Questions? Call 1-888-838-2872, weekdays, 8 am - 5 pm Eastern Time

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 one tablet (do not exceed maximum dosage) or decrease dose until you are comfortable.

AgeStarting DoseMaximum Dose
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 years1/2 tablet once a day1 tablet twice a day
children under 2 yearsask a doctorask a doctor

Inactive ingredients

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

Each tablet contains: calcium 25 mg

Storage

Store at 25 C (77 F) excursions permitted between 15-30 C (59-86 F).

GOLDLINE LABORATORIES, INC.

Sellersville, PA 18960

by: Time-Cap Labs, Inc.

Farmingdale, NY 11735

Repackaged by Cardinal Health

Zanesville, OH 43701

Principal Display Panel

Sennagen Tablets

Brand of Standardized Senna Concentrate

Equivalent to 8.6 Sennosides

Natural Vegetable

Laxative

10 Tablets

SENNA GEN 
sennosides tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-6163(NDC:0182-8215)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES (SENNOSIDES) SENNOSIDES8.6 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
MINERAL OIL 
Product Characteristics
ColorBROWNScoreno score
ShapeROUNDSize9mm
FlavorImprint CodeTCL;080
Contains    
Packaging
#Item CodePackage Description
1NDC:55154-6163-010 BLISTER PACK (BLISTER PACK) in 1 BAG
11 TABLET (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/07/2011
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIOperations
Cardinal Health188557102REPACK

Revised: 06/2011
 
Cardinal Health

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web1)