Fleet Bisacodyl Enema Ndc 0132-0703-36

Fleet Bisacodyl Enema Ndc 0132-0703-36
SPL v6
SPL
SPL Set ID 324e61eb-8f6b-48d7-85c2-b1b5642691c9
Route
RECTAL
Published
Effective Date 2025-06-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Deacetylbisacodyl (10 mg)
Inactive Ingredients
Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) Glycerin Methylparaben Octoxynol 9 Propylparaben Water Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2002-05-10

Description

Drug Facts

Purpose

Bisacodyl 10 mg .............Stimulant laxative/ bowel cleanser


Medication Information

Purpose

Bisacodyl 10 mg .............Stimulant laxative/ bowel cleanser

Description

Drug Facts

Uses
  • for relief of fecal impaction

  • for relief of occasional constipation

  • for removal of residue after barium administration

This product usually produces a bowel movement in 5 to 20 minutes.

Section 42229-5

Drug Facts

Warnings

For rectal use only.

Directions

Single Daily Dosage (per 24 hours)

adults and children 12 years and over 1 bottle per day
children under 12 years DO NOT USE
Do Not Use

when abdominal pain, nausea, or vomiting are present unless directed by a doctor.

Questions?

or www.fleetlabs.com

Tamper Evident: bottle sealed for safety. If bottle wrapper with fleet emblem is torn, damaged or missing, do not use.

Other Information

• store at temperatures not above 86˚ F (30˚ C)

Inactive Ingredients

carbomer 934P, glycerin, methylparaben, octoxynol-9, propylparaben, purified water, sodium hydroxide

Principal Display Panel

Fleet

Laxative

bisacodyl

Enema

If Pregnant Or Breast Feeding,

ask a health professional before use. 

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use and Ask A Doctor If You Have

      • rectal bleeding

      • no bowel movement within 20 minutes of using this product.

These symptoms may indicate a serious condition.

Ask A Doctor Before Using This Product If You
  • have a sudden change in bowel habits lasting more than 2 weeks

  • already used a laxative for more than 1 week

This product may cause abdominal discomfort, faintness, rectal burning, and mild cramps.


Structured Label Content

Uses
  • for relief of fecal impaction

  • for relief of occasional constipation

  • for removal of residue after barium administration

This product usually produces a bowel movement in 5 to 20 minutes.

Section 42229-5 (42229-5)

Drug Facts

Purpose

Bisacodyl 10 mg .............Stimulant laxative/ bowel cleanser

Warnings

For rectal use only.

Directions

Single Daily Dosage (per 24 hours)

adults and children 12 years and over 1 bottle per day
children under 12 years DO NOT USE
Do Not Use (Do not use)

when abdominal pain, nausea, or vomiting are present unless directed by a doctor.

Questions?

or www.fleetlabs.com

Tamper Evident: bottle sealed for safety. If bottle wrapper with fleet emblem is torn, damaged or missing, do not use.

Other Information (Other information)

• store at temperatures not above 86˚ F (30˚ C)

Inactive Ingredients (Inactive ingredients)

carbomer 934P, glycerin, methylparaben, octoxynol-9, propylparaben, purified water, sodium hydroxide

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Fleet

Laxative

bisacodyl

Enema

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.

Stop Use and Ask A Doctor If You Have (Stop use and ask a doctor if you have)

      • rectal bleeding

      • no bowel movement within 20 minutes of using this product.

These symptoms may indicate a serious condition.

Ask A Doctor Before Using This Product If You (Ask a doctor before using this product if you)
  • have a sudden change in bowel habits lasting more than 2 weeks

  • already used a laxative for more than 1 week

This product may cause abdominal discomfort, faintness, rectal burning, and mild cramps.


Advanced Ingredient Data


Raw Label Data

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