Walgreens Gentle Laxative Suppository
FDA Label NDC 0363-0466

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Walgreens Gentle Laxative (NDC 0363-0466). 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 active ingredient (in each suppository), uses, warnings, do not use, ask a doctor, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient (In Each Suppository)

Active Ingredient                                              Purpose

(in each Suppository)

Bisacodyl 10 mg.................................Stimulant Laxative

Uses

-for relief of occasional constipation

-this product generally produces bowel movement in 1/4 to 1 hour

Warnings

For rectal use only.

Do Not Use

Do not use

-when abdominal pain, nausea, or vomiting are present

-for a period of longer than 1 week

Ask A Doctor

Ask a doctor before use if you have noticed a sudden change in bowel habits that lasts over a period of 2 weeks

When Using This Product

When using this product it may cause abdominal discomfort, faintness, rectal burning and mild cramps

Stop Use And Ask A Doctor If

Stop use and ask a doctor if

-you have rectal bleeding

-you fail to have a bowel movement after using this product.  

This may indicate a serious condition

If Pregnant Or Breast-Feeding

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

Keep Out Of Reach Of Children

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Directions

-detach one suppository from the strip

-remove wrapper before inserting into the rectum

adults and children 12 years of age and older         1 suppository once daily            

children 6 to under 12 years                                     1/2 suppository once daily

children under 6 years                                              do not use

-detach one suppository from the strip
-remove wrapper before inserting into the rectum

adults and children 12 years of age and older            1 suppository once daily
children 6 to under 12 years                                       1/2 suppository once daily
children under 6 years                                                do not use

Other Information

Other information

-Store at room temperature.  Do not exceed 30oC (86oF)

-Lot No. & Exp. Date: see wrapper or box

Inactive Ingredient

Inactive ingredient  hydrogenated vegetable oil

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