Senna S: Package Insert and Label Information

SENNA S- docusate sodium and sennosides tablet, coated
Medline Industries, LP

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)

  • Docusate sodium 50 mg
  • Sennosides 8.6 mg

Purpose

Stool softener laxative

Stimulant laxative

Uses

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

Warnings

Do not use

  • this product if you are presently 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
  • a sudden change in bowel movements that persists 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
  • if you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed maximum dosage) or decrease dose until you are comfortable

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, sodium 6 mg (VERY LOW SODIUM)
  • store at 25°C (77°F); excursions permitted between 15-30°C (59-86°F)

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, D&C yellow#10 aluminum lake, FD&C yellow#6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide

Questions or comments?

Call toll free 1-800-MEDLINE (633-5463)
Monday-Friday 9AM-5PM CST

Manufacturing Information

Manufactured for:
Medline Industries, LP
Three Lakes Drive, Northfield, IL 60093 USA
Made in USA with domestic and foreign materials
www.medline.com
1-800-MEDLINE (633-5463)
REF: OTCM00011
V1 RE22HND

Package Label

Label V1 RE22HND
(click image for full-size original)

SENNA S
sennosides and docusate sodium tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-989
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
TITANIUM DIOXIDE
CARNAUBA WAX
SILICON DIOXIDE
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
FD&C YELLOW NO. 6 (FOOD YELLOW 3 FREE ACID)
CROSCARMELLOSE SODIUM (CROSCARMELLOSE)
D&C YELLOW NO. 10
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM BENZOATE
STEARIC ACID
Product Characteristics
Color orange Score score with uneven pieces
Shape ROUND Size 10mm
Flavor Imprint Code TCL;081
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53329-989-62 60 TABLET, COATED in 1 BOTTLE, PLASTIC None
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 05/22/2018
Labeler — Medline Industries, LP (025460908)
Registrant — Medline Industries, LP (025460908)

Revised: 12/2022 Medline Industries, LP

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