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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Drug Facts

Active ingredient (in each tablet)

Sennosides 8.6 mg

Purpose

Laxative

Uses

  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement within 6- 12 hours.

Warnings

Do not use

  • laxative products for longer than 1 week unless directed by a doctor

Ask a doctor before using 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.

Directions

  • take preferably at bedtime or as directed by a doctor
agestarting dosage maximum dosage 
adults and children 12 years of age 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 25 mg
  • store at 25o C (77o F); excursions permitted between 15_30oC (59_86oF)

Inactive Ingredients

croscarmellose sodium, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol*, polyvinyl alcohol, silicon dioxide*, stearic acid*, talc

Questions or comments?

Call free 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

†Compare to the active ingredient in Senokot®

Natural Laxative

Sennosides, 8.6 mg

Laxative

Natural Vegetable laxative ingredient

gentle, overnight relief

Tablets

†This product is not manufactured or distributed by Purdue Products L.P., distributor of Senokot®.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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

Manufactured by:

Avema Pharma Solutions

10400 NW 29th Terrace

Miami, FL 33172

Product Label

Sennosides 8.6 mg

Natural Laxative Sennosides Brown Tablet

SENNA LAXATIVE 
sennosides tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63548-0486
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)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize9mm
FlavorImprint Code 0813;AV
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63548-0486-11000 in 1 BOTTLE; Type 0: Not a Combination Product01/02/201001/02/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/02/201001/02/2024
Labeler - PLD Acquisitions LLC DBA Avéma Pharma Solutions (804087794)

Revised: 2/2023
Document Id: e9bcc787-4fd6-4859-af6f-bb95f8669908
Set id: 51db7d70-c0d8-459c-b78f-59409ce536e7
Version: 3
Effective Time: 20230209
 
PLD Acquisitions LLC DBA Avéma Pharma Solutions