Senna Laxative: Package Insert and Label Information

SENNA LAXATIVE- sennosides 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 (in each tablet)

Sennosides 8.6 mg

Purpose

Laxative

Uses

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

Warnings

Do not use

  • 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 (1-800-222-1222) 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 30 mg
  • store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

croscarmellose sodium, anhydrous dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, silicon dioxide, talc, triacetin

Questions or comments?

Call 1-833-358-6431 Monday to Friday 9:00am to 7:00pm EST

Principal Display Panel

COMPARE TO SENOKOT® ACTIVE INGREDIENT*

Senna laxative

Natural Vegetable Laxative Ingredient

Gently, overnight relief

SENNOSIDES, 8.6 MG

TABLETS

*This product is not manufactured or distributed by Avrio Health L.P., distributor of Senokot®.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by McKesson Corp.,

via Strategic Sourcing Services LLC, Memphis, TN 38141

www.sunmarkbrand.com

Product Labeling

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

SUNMARK Senna Laxative

SENNA LAXATIVE
sennosides tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-0164
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
HYPROMELLOSES
MAGNESIUM STEARATE
TALC
CELLULOSE, MICROCRYSTALLINE
TRIACETIN
SILICON DIOXIDE
Product Characteristics
Color brown Score no score
Shape ROUND Size 10mm
Flavor Imprint Code PS23
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70677-0164-1 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC
1 100 TABLET in 1 BOTTLE, PLASTIC This package is contained within the BOX (70677-0164-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 08/01/2022
Labeler — Strategic Sourcing Services LLC (116956644)

Revised: 08/2022 Strategic Sourcing Services LLC

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