GENTLE RELIEF SENNA LAXATIVE- sennosides tablet 
PLD Acquisitions LLC DBA Avéma Pharma Solutions

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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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

warnings

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

label
GENTLE RELIEF SENNA LAXATIVE 
sennosides tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63548-0068
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorBROWNScoreno score
ShapeROUNDSize9mm
FlavorImprint Code S3;S8;TCL080
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63548-0068-1100 in 1 BOTTLE; Type 0: Not a Combination Product04/30/201202/28/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33404/30/201202/28/2017
Labeler - PLD Acquisitions LLC DBA Avéma Pharma Solutions (804087794)

Revised: 3/2017
 
PLD Acquisitions LLC DBA Avéma Pharma Solutions