SENNA-S LAXATIVE WITH STOOL SOFTENER: Package Insert and Label Information

SENNA-S LAXATIVE WITH STOOL SOFTENER- docusate sodium and sennosides tablet
Basic Drugs, Inc.

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 50mg

Sennosides from Senna Concentrate 8.6mg

Purpose

Stool softener

Laxative

Uses

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

Warnings

Do not use

• if you are 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 a period of 2 weeks

Stop use and ask a doctor if

• you have rectal bleeding
• you 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• take only by mouth
• 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 of age	ask a doctor	ask a doctor

Other information

• each tablet contains: calcium 8 mg, sodium 3 mg
• store between 15° — 30°C (59° — 86°F)

Inactive ingredients

Croscarmellose sodium, D&C Yellow #10, dicalcium phosphate, FD&C Yellow # 6, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Questions?

937-898-4010

SENNA-S LAXATIVE WITH STOOL SOFTENER sennosides tablet

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0761-0910 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 CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 ANHYDROUS DIBASIC CALCIUM PHOSPHATE FD&C YELLOW NO. 6 MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED TALC TITANIUM DIOXIDE

Product Characteristics Color orange Score no score Shape ROUND Size 9mm Flavor Imprint Code PH32 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0761-0910-02 100 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 12/15/2021

Labeler — Basic Drugs, Inc. (052155082)

Revised: 01/2022 Basic Drugs, Inc.