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CVS Gentle Laxative

CVS Pharmacy Gentle Laxatives 8 ct

Approved
Approval ID

9c6a651a-f062-4784-9d82-156f9f745223

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 13, 2025

Manufacturers
FDA

CVS Pharmacy

DUNS: 062312574

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Bisacodyl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59779-107
Application NumberM007
Product Classification
M
Marketing Category
C200263
G
Generic Name
Bisacodyl
Product Specifications
Route of AdministrationRECTAL
Effective DateJuly 13, 2025
FDA Product Classification

INGREDIENTS (2)

PALM KERNEL OILInactive
Code: B0S90M0233
Classification: IACT
BISACODYLActive
Quantity: 10 mg in 1 1
Code: 10X0709Y6I
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/23/2014

Product Label

Product Label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/18/2014

Uses

Uses - For relief of occasional constipation and irregularity

-This product generally produces bowel movement in 15 minutes to 1 hour

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 9/18/2014

If pregnant or breast-feeding

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/18/2014

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.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 9/18/2014

Stop use and ask a doctor

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

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 9/18/2014

Do not use

Do not use - more than once per day - for a period of longer than one week unless directed by a doctor - laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 9/18/2014

Ask a doctor

Ask a doctor before use if you have - noticed a sudden change in bowel habits that persists over a period of two weeks

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/18/2014

Active Ingredient (in each Suppository)

Purpose

Bisacodyl USP, 10 mg.................................Stimulant Laxative

WARNINGS SECTION

LOINC: 34071-1Updated: 9/18/2014

Warnings

For rectal use only.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 9/18/2014

When using this product

When using this product - May cause abdominal discomfort, faintness, rectal burning, and mild cramps

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 2/1/2021

Directions

Adults and children 12 years of age and older Children 6 to under 12 years Children under 6

One suppository once daily 1/2 suppository once daily Ask doctor.

-Detach one suppository from the strip and remove from foil - Carefully insert one suppository well into the rectum

-Do not use more than once per day

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 9/18/2014

Other information

Other information - Store at room temperature: 15 o - 30 oC (59 o - 86 oF). Do not exceed 30 oC (86 oF) - Individually sealed for your protection. Do not use if foil is torn or open

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/18/2014

Inactive ingredient

Inactive ingredient Hydrogenated vegetable oil

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/18/2014

Purpose

Stimulant Laxative

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CVS Gentle Laxative - FDA Drug Approval Details