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

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

(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