PLUS PHARMA SENNA STANDARDIZED SENNA CONCENTRATE 8.6 MG SENNOSIDES EACH- sennosides tablet, film coated 
Proficient Rx LP

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 in 6-12 hours

Warnings

Do not use

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

Ask a doctor before 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.

Directions

take preferably at bedtime or as directed by a doctor

age

starting dosage

maximum dosage

adults and children 12 years of age and older

2 tablets once a day

4 tablets twice a day

children 6 to under 12 years of age

1 tablet once a day

2 tablets twice a day

children 2 to under 6 years of age

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 20 mg
Store at room temperature
Do not use if imprinted seal under cap is broken or missing

Inactive ingredients

Calcium carbonate, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, propylene glycol, silicon dioxide, sodium sulfate, stearic acid, triacetin.

Questions?

If you have any questions or comments,or to report an adverse event, please contact (800) 795-9775.

Principal Display Panel

NDC 63187-683-00

PlusPHARMA

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

Senna

Standardized Senna Concentrate

8.6 mg Sennosides Each

Natural Vegetable Laxative Ingredient

*Compare to Senokot®

Product color may vary slightly due to nature of ingredients.

*Plus Pharma  is not affiliated with the owner of the registered trademark Senokot®.

100 TABLETS

63187-683-00
PLUS PHARMA SENNA  STANDARDIZED SENNA CONCENTRATE 8.6 MG SENNOSIDES EACH
sennosides tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-683(NDC:51645-851)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
SODIUM SULFATE (UNII: 0YPR65R21J)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorbrownScore2 pieces
ShapeROUND (Biconvex) Size9mm
FlavorImprint Code GPI;W2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63187-683-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2016
2NDC:63187-683-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2016
3NDC:63187-683-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2016
4NDC:63187-683-00100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/27/2006
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079196022REPACK(63187-683) , RELABEL(63187-683)

Revised: 11/2019
Document Id: 4e48ba59-9b47-4427-9369-43edfe8024f2
Set id: 9641cbbb-cf36-4310-b801-026298ae3536
Version: 3
Effective Time: 20191101
 
Proficient Rx LP