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Senna-s laxative with stool softener - Prescription Drug Labeling

Product NDC Code 0761-0910
Drug Name

Senna-s laxative with stool softener

Type Brand
Active Ingredients
Docusate sodium 50 mg/1
Sennosides 8.6 mg/1
Route ORAL
Dosage Form TABLET
RxCUI drug identifier 998740
Application Number part334
Labeler Name Basic Drugs, Inc.
Packages
Package NDC Code Description
0761-0910-02 100 tablet in 1 bottle (0761-0910-02)

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each tablet) Docusate Sodium 50mg Sennosides from Senna Concentrate 8.6mg

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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
agestarting dosagemaximum dosage
adults and children 12 years of age and over2 tablets once a day4 tablets twice a day
children 6 to under 12 years1 tablet once a day2 tablets twice a day
children 2 to under 6 years1/2 tablet once a day1 tablet twice a day
children under 2 years of ageask a doctorask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
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

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses relieves ocasional constipation (irregularity) generally produces bowel movement in 6-12 hours.

Purpose

Information about the drug product’s indications for use.
Purpose Stool softener Laxative

Spl product data elements

Usually a list of ingredients in a drug product.
SENNA-S LAXATIVE WITH STOOL SOFTENER SENNOSIDES DOCUSATE SODIUM DOCUSATE 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 SENNOSIDES SENNOSIDES PH32

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
01b_PDP_Senna-S Laxative w. stool softner.jpg 01b_DF1_Senna-S.jpg 01b_DF2_Senna-S.jpg

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
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.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other information each tablet contains: calcium 8 mg, sodium 3 mg store between 15° - 30°C (59° - 86°F)

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? 937-898-4010

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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.

Disclaimer: Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API