OTC Medication Information: Senna Laxative

SENNA LAXATIVE- 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 ingredient (in each tablet)

Sennosides 8.6 mg

Purpose

Laxative

Uses

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

Warnings

Do not use

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

Ask a doctor before using 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 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 25 mg
  • store at 25o C (77o F); excursions permitted between 15_ 30o C (59_ 86o F)

Inactive Ingredients

croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, liquid paraffin*, magnesium stearate, maltodextrin*, microcrystalline cellulose, mineral oil*, polyethylene glycol*, polyvinyl alcohol*, silicon dioxide*, sodium lauryl sulfate*, stearic acid*, talc*

*contains one or more of these ingredients

Questions or comments?

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

Principal Display Panel

Compare to Senokot® active ingredient†

Senna Laxative

Sennosides, 8.6 mg

Natural Vegetable laxative ingredient

gentle, overnight relief

Tablets

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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

DISTRIBUTED BY: CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

Product Label

Sennosides 8.6 mg
(click image for full-size original)

Leader Senna Laxative Brown Tablets

SENNA LAXATIVE
sennosides tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49781-148
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SENNOSIDES (SENNOSIDES) SENNOSIDES 8.6 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYPROMELLOSES
MAGNESIUM STEARATE
MALTODEXTRIN
CELLULOSE, MICROCRYSTALLINE
MINERAL OIL
SILICON DIOXIDE
STEARIC ACID
TALC
SODIUM LAURYL SULFATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 9mm
Flavor Imprint Code 0813;AV;TCL080;S8
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49781-148-51 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC
1 100 TABLET in 1 BOTTLE, PLASTIC This package is contained within the BOX (49781-148-51)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part334 02/29/2016 12/31/2022
Labeler — Cardinal Health (Leader) 49781 (097537435)

Revised: 11/2019 Cardinal Health (Leader) 49781

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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