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SennaLax-S by Par Pharmaceutical

Medically reviewed on Sep 10, 2018

Dosage form: tablet, film coated
Ingredients: DOCUSATE SODIUM 50mg, SENNOSIDES 8.6mg
Labeler: Par Pharmaceutical
NDC Code: 0603-0283

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.

SennaLax-S Tablets

Active ingredients (in each tablet)

Docusate sodium, 50 mg
Sennosides, 8.6 mg

Purpose

Stool Softener
Stimulant laxative

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

Warnings

Do not use
  • laxative products for longer than 1 week unless told to do so by a doctor
  • if you are presently taking mineral oil, unless told to do so by a doctor

Ask a doctor before use if you have
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 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 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
  • take preferably at bedtime or as directed by a doctor
agestarting dosemaximum dosage
adults & children 12 years and over2 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

Other information
  • each tablet contains: calcium 30 mg, sodium 3 mg VERY LOW SODIUM
  • do not use if imprinted safety seal under cap is missing or damaged.
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).
  • keep tightly closed.

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive ingredients

colloidal silicon dioxide, D&C yellow No. 10, dicalcium phosphate, ethanol, FD&C yellow No. 6, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, pregelatinized starch, silicon dioxide, sodium benzoate, stearic acid, talc, titanium dioxide.

Mfg. for:
Qualitest Pharmaceuticals
Huntsville, AL 35811

REV. 01/10

PRINCIPAL DISPLAY PANEL
SENNALAX-S 
senna and docusate sodium tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0603-0283
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM50 mg
SENNOSIDES (SENNOSIDES) SENNOSIDES8.6 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
D&C YELLOW NO. 10 
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
ALCOHOL 
FD&C YELLOW NO. 6 
HYPROMELLOSE 2208 (100 MPA.S) 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
MINERAL OIL 
POLYETHYLENE GLYCOLS 
STARCH, CORN 
SODIUM BENZOATE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeS90
Contains    
Packaging
#Item CodePackage Description
1NDC:0603-0283-21100 TABLET, FILM COATED in 1 BOTTLE
2NDC:0603-0283-321000 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33407/26/200706/30/2020
Labeler - Par Pharmaceutical (011103059)
Registrant - Sunrise Pharmaceutical Inc (168522378)
Establishment
NameAddressID/FEIOperations
Sunrise Pharmaceutical Inc.168522378MANUFACTURE(0603-0283)

 
Par Pharmaceutical

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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