Senokot-s
FDA Label NDC 42787-105

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ajes Pharmaceuticals,llc for the product Senokot-s (NDC 42787-105). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Otc - Purpose

Purpose

Stool Softner

Laxative

Otc - Keep Out Of Reach Of Children

Keep Out of Reach of Children

In case of overdose, get medical help or contact

a Poison Control Center right away.

Indications & Usage

Uses

Relieves occasional constipation (irregularity)

Generally causes a bowel movement in 6-12 hours

Warnings

Warnings

Do Not Use

If you are now taking mineral oil,

unless directed by a doctor

Laxative products for longer than 1 week,

unless directed by a doctor

Dosage & Administration

Directions - take preferably at bedtime or as directed by a doctor

Age                                                                     Starting dose                                    Maximum Dose

Adults and children 12 years of age or older     2 tablets once a day -                               4 tablets twice a day

children 6 to 12 years of age -                         1 tablet once a day                                    2 tablets twice a day

children 2 to 6 years of age                              1/2 tablet once a day                              1 tablet twice a day

children under 2 years of age                           ask a doctor  

Inactive Ingredient

Enter section

Otc - Ask Doctor

Ask a doctor before use if your have rectal bleeding or fail to have

a bowel movement after use of a laxative. These may be signs of   

a serious condition

Pregnancy

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

Package Label.Principal Display Panel

Copy Of Label (Stool 50)

Copy Of Label (Stool 50)

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