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cvs pharmacy ®
SPL v4
SPL
SPL Set ID 10a9bd9a-181b-69ba-e063-6294a90ac458
Route
rectal
Published
Effective Date 2014-09-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
deacetylbisacodyl (10 mg)
Inactive Ingredients
palm kernel oil

Identifiers & Packaging

Pill Appearance
Shape: bullet Color: white Size: 32 mm
Marketing Status
otc monograph drug active Since 2014-09-18

Purpose

Stimulant Laxative

Description

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


Medication Information

Warnings

For rectal use only.

Uses

Uses - For relief of occasional constipation and irregularity

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

Purpose

Stimulant Laxative

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

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

Description

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

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

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

Product Label

Inactive Ingredient

Inactive ingredient  Hydrogenated vegetable oil

When Using This Product

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

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

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.

Active Ingredient (in Each Suppository)

                                                                   Purpose

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


Structured Label Content

Warnings

For rectal use only.

Uses

Uses - For relief of occasional constipation and irregularity

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

Purpose

Stimulant Laxative

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

Other Information (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

Do Not Use (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

Ask A Doctor (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

Product Label

Inactive Ingredient (Inactive ingredient)

Inactive ingredient  Hydrogenated vegetable oil

When Using This Product (When using this product)

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

Stop Use and Ask A Doctor (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

If Pregnant Or Breast Feeding (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)

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

Active Ingredient (in Each Suppository) (Active Ingredient (in each Suppository))

                                                                   Purpose

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


Advanced Ingredient Data


Raw Label Data

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