OTC Medication Information: Senna

SENNA- sennosides a and b tablet
Strategic Sourcing Services LLC

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 Ingredient

Sennosides 8.6 mg

Purpose

Laxative

Uses:

Relieves occasional constipation (irregularity)

Generally produces a bowel movement in 6 — 12 hours

Warning

Do not use Laxative products for longer than 1 week, unless directed by a doctor

Ask a doctor befor 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.

Other Information

  • each tablet contains: calcium 25 mg/tablet

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • do not use if imprinted safety seal under cap is broken or missing
  • This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot®

Directions

Take preferably at bedtime or as directed by a doctor.

Age Starting Dosage Maximum Dosage
adults and children 12 years of age or older 2tablets once a day 4 tablets twice a day
children 6 to under 6 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

Inactive Ingredients

Colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, *dicalcium phosphate anhydrous, hypermellose, maltodextrin, magnesium stearate, microcrystalline cellulose, *mineral oil, *polyethylene glycol (PEG), stearic acid, talc, triacetin.

*May also contain.

Package Labeling

Compare to the active ingredient in Senokot

Senna Laxative
Natural Vegetable Laxative

Standardized Senna Concentrate

100 Senna TabletsSennosides 8.6mg each

label
(click image for full-size original)
SENNA sennosides tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62011-0162
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SENNOSIDES A AND B (SENNOSIDES A AND B) SENNOSIDES A AND B 8.6 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
HYPROMELLOSES
MALTODEXTRIN
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
MINERAL OIL
POLYETHYLENE GLYCOL, UNSPECIFIED
STEARIC ACID
TALC
TRIACETIN
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 9mm
Flavor Imprint Code S3;S8;TCL080
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62011-0162-1 1 BOTTLE in 1 BOX contains a BOTTLE
1 100 TABLET in 1 BOTTLE This package is contained within the BOX (62011-0162-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part334 05/18/2012 10/01/2019
Labeler — Strategic Sourcing Services LLC (116956644)

Revised: 09/2019 Strategic Sourcing Services LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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