OTC Medication Information: Sennosides and Docusate Sodium

SENNOSIDES AND DOCUSATE SODIUM- sennosides and docusate sodium tablet
Reliable-1 Laboratories 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.

Drugs Facts

Active ingredient (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Purpose

Stool softener

Stimulant laxative

Uses

relieves occasional constipation (irregularity)

generally produces a bowel movement in 6 to 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

Warnings

Ask a doctor before use if you have

stomach pain

nausea

vomiting

noticed a sudden change in bowel habits that continues over a period of 2 weeks

Warnings

Stop use and ask a doctor if you have rectal bleeding or fail to have bowel movement after use of a laxative. These may indicate a serious condition.

Warnings

If pregnant or breast-feeding, ask a health professional before use.

Warnings

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

do not exceed maximum dosage

age starting dosage maximun dosage
adults and children 12 years of age or older 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 4 mg, sodium 8 mg

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C Yello #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, titanium dioxide

Questions or comments?

Call 516-341-0666

8:30am-4:30pm ET, Mon-Fri

NDC 69618-065-01

Senna Plus

Sennosides 8.6 mg

Docusate sodium 50 mg

NATURAL VEGETABLE

LAXATIVE AND

STOOL SOFTENER

100 TABLETS

*Compare to active ingredients in SENOKOT-S®

Rev 01 Reliable-1 Senna Plus 100 ct
(click image for full-size original)
SENNOSIDES AND DOCUSATE SODIUM
sennosides, docusate sodium tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69618-065
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SENNOSIDES (SENNOSIDES) SENNOSIDES 8.6 mg
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 50 mg
Inactive Ingredients
Ingredient Name Strength
TITANIUM DIOXIDE
SODIUM BENZOATE
D&C YELLOW NO. 10
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
CROSCARMELLOSE SODIUM
FD&C YELLOW NO. 6
HYPROMELLOSES
SILICON DIOXIDE
Product Characteristics
Color orange Score no score
Shape ROUND Size 9mm
Flavor Imprint Code S6
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69618-065-01 100 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 08/01/2020
Labeler — Reliable-1 Laboratories LLC (079718111)

Revised: 08/2023 Reliable-1 Laboratories LLC

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.

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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