Senna S: Package Insert and Label Information

SENNA S- docusate sodium and sennosides tablet
Cardinal Health (Leader) 49781

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.

Active ingredients (in each tablet)

Docusate sodium 50 mg
Sennosides 8.6 mg

Purpose

Stool softener

Laxative

Uses

  • relieves occasional constipation (irregularity)
  • generally produces 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 periodof 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 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 20 mg
  • each tablet contains: sodium 6 mg VERY LOW SODIUM
  • store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

carnauba wax*, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake*, FD&C red #40 aluminum lake*, FD&C yellow #6 aluminum lake, hypromellose*, magnesium stearate, maltodextrin*, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol*, silicon dioxide, sodium benzoate*, stearic acid, talc*, titanium dioxide

*contains one or more of these ingredients

Questions or comments?

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

Principal Display Panel

Compare to Senokot-S® active ingredients†

Senna-S

Stool Softener Plus Laxative

Docusate sodium, 50 mg/Sennosides 8.6 mg

Natural vegetable laxative

relieves constipation

TABLETS

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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

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

DSITRIBUTED BY CARDINAL HEALTH, DUBLIN OHIO 43017

www.leader.com

1-800-200-6313

Product Labeling

Docusate sodium 50 mg, Sennosides 8.6 mg
(click image for full-size original)

Leader Senna-S Tablets

SENNA S
docusate sodium, sennosides tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49781-149
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 50 mg
SENNOSIDES (SENNOSIDES) SENNOSIDES 8.6 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
FD&C BLUE NO. 2
FD&C RED NO. 40
FD&C YELLOW NO. 6
HYPROMELLOSES
MAGNESIUM STEARATE
MALTODEXTRIN
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
SILICON DIOXIDE
SODIUM BENZOATE
STEARIC ACID
TALC
TITANIUM DIOXIDE
ALUMINUM OXIDE
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code TCL081;0805;AV;S35
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49781-149-60 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC
1 60 TABLET in 1 BOTTLE, PLASTIC This package is contained within the BOX (49781-149-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part334 01/31/2016 12/31/2021
Labeler — Cardinal Health (Leader) 49781 (097537435)

Revised: 11/2019 Cardinal Health (Leader) 49781

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