Onelax

Onelax
SPL v4
SPL
SPL Set ID be4eeb4d-df29-45dc-94ff-933e52c8b6f6
Route
RECTAL
Published
Effective Date 2024-09-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Deacetylbisacodyl (10 mg)
Inactive Ingredients
Fat, Hard

Identifiers & Packaging

Pill Appearance
Shape: oval Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-13
Description

Bisacodyl USP, 10  mg

Purpose

Laxative

Medication Information

Purpose

Laxative

Description

Bisacodyl USP, 10  mg

Uses
  • for relief of occasional constipation
  • this product usually produces bowel movement in 1/4 to 1 hour

Section 50565-1

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

Section 51945-4

Warnings

For rectal use only.

Directions
  • adults and children 12 years of age and older
  • detach one suppository from the strip
  • remove from wrapper before inserting into the rectum
  • the rectal suppository dose is one suppository per day or as directed by a doctor
  • children under 12 years of age consult a doctor
Other Information

store below 30° C (86° F)

Inactive Ingredient

hydrogenated vegetable oil

Manufactured for:

Akron Pharma Inc.,

Fairfield, NJ-07004

www.akronpharma.com

When Using This Product

it may cause abdominal discomfort, faintness, rectal burning and mild cramps

Do Not Use Laxative Products
  • when abdominal pain, nausea or vomiting are present
  • for a period longer than one week

Stop Use and Ask A Doctor If

rectal bleeding occurs, or you fail to have a bowel movement after using a laxative. This may indicate a serious condition.

If Pregnant Or Breast Feeding

ask a health professional before use.

Ask A Doctor Before Use If You Have

noticed a sudden change in bowel habits that persist over a period of 2 weeks

Active Ingredients (per Suppository)

Bisacodyl USP, 10  mg

Structured Label Content

Uses
  • for relief of occasional constipation
  • this product usually produces bowel movement in 1/4 to 1 hour

Section 50565-1 (50565-1)

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

Section 51945-4 (51945-4)

Purpose

Laxative

Warnings

For rectal use only.

Directions
  • adults and children 12 years of age and older
  • detach one suppository from the strip
  • remove from wrapper before inserting into the rectum
  • the rectal suppository dose is one suppository per day or as directed by a doctor
  • children under 12 years of age consult a doctor
Other Information (Other information)

store below 30° C (86° F)

Inactive Ingredient (Inactive ingredient)

hydrogenated vegetable oil

Manufactured for:

Akron Pharma Inc.,

Fairfield, NJ-07004

www.akronpharma.com

When Using This Product (When using this product)

it may cause abdominal discomfort, faintness, rectal burning and mild cramps

Do Not Use Laxative Products (Do not use laxative products)
  • when abdominal pain, nausea or vomiting are present
  • for a period longer than one week

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

rectal bleeding occurs, or you fail to have a 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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

noticed a sudden change in bowel habits that persist over a period of 2 weeks

Active Ingredients (per Suppository) (Active Ingredients (per suppository))

Bisacodyl USP, 10  mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:36.588678 · Updated: 2026-03-14T23:13:25.872506