Gentle Relief Senna Laxative

Dosage form: tablet
Ingredients: SENNOSIDES A AND B 8.6mg
Labeler: Avema Pharma Solutions
NDC Code: 63548-0068

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.

Gentle Relief Senna Laxative

Active Ingredient

Sennosides 8.6 mg

Purpose

Laxative

Uses:

Relieves occasional constipation (irregularity)

Generally produces a bowel movement in 6 - 12 hours

Do not use Laxative products for longer than 1 week, unless directed by a doctor



Ask a doctor befor 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 right away.

Other Information
  • each tablet contains: calcium 25 mg/tablet
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • do not use if imprinted safety seal under cap is broken or missing
  • This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot®

Directions

Take preferably at bedtime or as directed by a doctor.


Age
Starting Dosage
Maximum Dosage
adults and children 12 years of age or older
2tablets once a day
4 tablets twice a day
children 6 to under 6 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

Inactive Ingredients

Colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, *dicalcium phosphate anhydrous, hypermellose, maltodextrin, magnesium stearate, microcrystalline cellulose, *mineral oil, *polyethylene glycol (PEG), stearic acid, talc, triacetin. 

*May also contain.

Package Labeling

Compare to the active ingredient in Senokot

Senna Laxative
Natural Vegetable Laxative

Standardized Senna Concentrate

100 Senna Tablets
Sennosides 8.6mg each

GENTLE RELIEF SENNA LAXATIVE 
sennosides tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63548-0068
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES A AND B (SENNOSIDES A AND B) SENNOSIDES A AND B8.6 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
HYPROMELLOSES 
MALTODEXTRIN 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
MINERAL OIL 
POLYETHYLENE GLYCOL 
STEARIC ACID 
TALC 
TRIACETIN 
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize9mm
FlavorImprint CodeS3;S8;TCL080
Contains    
Packaging
#Item CodePackage Description
1NDC:63548-0068-1100 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33404/30/2012
Labeler - Avema Pharma Solutions (804087794)

Revised: 04/2012
 
Avema Pharma Solutions

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
(web3)