Onelax Suppository
FDA Label NDC 71399-8460

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Akron Pharma Inc for the product Onelax (NDC 71399-8460). 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 ingredients (per suppository), purpose, otc - keep out of reach of children, uses, warnings, do not use laxative products, ask a doctor before use if you have, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (Per Suppository)

Bisacodyl USP, 10  mg

Purpose

Laxative

Otc - 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.

Uses

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

Warnings

For rectal use only.

Do Not Use Laxative Products

  • when abdominal pain, nausea or vomiting are present
  • for a period longer than one week

Ask A Doctor Before Use If You Have

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

When Using This Product

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

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.

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

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