SENNA LEAF and DOCUSATE SODIUM

Dosage form: tablet, film coated
Ingredients: SENNA LEAF 8.6mg, DOCUSATE SODIUM 50mg
Labeler: HIMPRIT PHARMACHEM PVT LTD
NDC Code: 65437-035

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.

SENNA 8.6mg & DOCUSATE SODIUM 50mg

Drug Facts

Active ingredients (in each tablet)Purpose
Docusate sodium 50 mgStool softener
Sennosides 8.6 mgLaxative

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

Warnings

Do not use

  • if you are now taking mineral oil, unless directed by a doctor
  • 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
agestarting dosagemaximum dosage
adults and children 12 years of age or older2 tablets once a day4 tablets twice a day
children 6 to under 12 years1 tablet once a day2 tablets twice a day
children 2 to under 6 years1/2 tablet once a day1 tablet twice a day
children under 2 yearsask a doctorask a doctor

Inactive Ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, PEG 8000, sodium benzoate, stearic acid, tartaric acid, titanium dioxide

PRINCIPAL DISPLAY PANEL - Shipping Label

SENNA 8.6mg & DOCUSATE SODIUM 50mg
Orange Tablets

Each Tablet Contains:
CALCIUM SENNOSIDES 8.6mg
DOCUSATE SODIUM 50mg

Lot No:Quantity:
Mfg Date:Jar No:
Exp Date:NDC NO: 65437-035-50

WARNING:
KEEP OUT OF THE REACH OF CHILDREN

STORE AT CONTROLLED ROOM TEMPERATURE OF 59 - 77 F (15 - 25 C)
PROTECT FROM LIGHT,MOISURE AND FREEZING.

THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT
CONFORMANCE WITH THE F.D. & C. ACT AND REGULATIONS THEREUNDER.

MANUFACTURED BY:
MANUFACTURED CODE NO Guj/Drugs/G/1362
LABELLER CODE # 14803

MANUFACTURED FOR:
HIMPRIT PHARMACHEM PVT.LTD.
"LAKULISH" R.V.DESAI ROAD
NEXT TO NAVAPURA POLICE STATION
BARODA, INDIA 390 001

SENNA LEAF AND DOCUSATE SODIUM 
senna leaf and docusate sodium tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65437-035
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNA LEAF (SENNA LEAF) SENNA LEAF8.6 mg
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM50 mg
Inactive Ingredients
Ingredient NameStrength
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
CROSCARMELLOSE SODIUM 
STEARIC ACID 
POLYETHYLENE GLYCOL 
D&C YELLOW NO. 10 
TITANIUM DIOXIDE 
WATER 
SILICON DIOXIDE 
MAGNESIUM STEARATE 
HYPROMELLOSE 
CARNAUBA WAX 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize9mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:65437-035-501 BAG (BAG) in 1 DRUM
150000 TABLET, FILM COATED (TABLET) in 1 BAG
2NDC:65437-035-701 BAG (BAG) in 1 DRUM
275000 TABLET, FILM COATED (TABLET) in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33404/01/2010
Labeler - HIMPRIT PHARMACHEM PVT LTD (917261992)

Revised: 03/2010
 
HIMPRIT PHARMACHEM PVT LTD

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.

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