SENNA LAXATIVE- senna tablet, film coated 
PD-Rx Pharmaceuticals, Inc.

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Drug Facts

Active ingredient (in each tablet)

Sennosides 8.6mg

Purpose

Laxative

Uses

Warnings


Do not use

for more than one week unless directed by a doctor

Ask a doctor before use if you

  • have abdominal pain, nausea, or vomiting
  • are taking mineral oil
  • noticed a sudden change in bowel habits that last over 2 weeks

Stop use and ask a doctor if

  • you have no bowel movement within 12 hours
  • you have rectal bleeding

These could be signs of 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

Age
Starting Dose
Maximum Dose
adults and children 12 years of age and older
2 tablets once a day preferably at bedtime; increase if needed, or as directed by a doctor
4 tablets twice a day, in the morning and at bedtime
children under 12 years
ask a doctor
ask a doctor

Other information

Inactive ingredients:

croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil

Questions?

Adverse drug event call: (866) 562-2756

16 HOW SUPPLIED

Senna Laxative Tablets are available as follows:

8.6 mg: Brown, round, scored tablet, debossed “SB”. Available in bottles of

10 tablets (NDC 43063-838-10)

30 tablets (NDC 43063-838-30)

image

SENNA LAXATIVE 
senna tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43063-838(NDC:16103-363)
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
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize10mm
FlavorImprint Code S8
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43063-838-1010 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2021
2NDC:43063-838-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00701/24/2007
Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
NameAddressID/FEIBusiness Operations
PD-Rx Pharmaceuticals, Inc.156893695repack(43063-838)

Revised: 10/2023
Document Id: 06d12bcf-db68-fe1b-e063-6294a90a6d1e
Set id: 2b03d07c-ea4f-4663-bcc3-20ebdf83b7aa
Version: 6
Effective Time: 20231003
 
PD-Rx Pharmaceuticals, Inc.