Pedia-lax Liquid
FDA Label NDC 0132-0190

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by C.b. Fleet Company, Inc. for the product Pedia-lax (NDC 0132-0190). 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 ingredient (in each 2.7 ml average delivered dose), uses, warnings, ask a doctor before using any laxative if the child has, stop using this product and consult a doctor if the child has, keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each 2.7 Ml Average Delivered Dose)

Glycerin 2.8 g, Hyperosmotic Laxative

Uses

  • For relief of occasional constipation
  • This product generally produces bowel movement in 1/4 to 1 hour

Warnings

For rectal use only

May cause rectal discomfort or a burning sensation.

Ask A Doctor Before Using Any Laxative If The Child Has

  • abdominal pain, nausea or vomiting
  • a sudden change in bowel habits lasting more than 2 weeks
  • already used a laxative for more than 1 week
  • if constipation continues after one week of use, contact your child's doctor

Stop Using This Product And Consult A Doctor If The Child Has

  • rectal bleeding
  • no bowel movement within 1 hour of using this product

    • These symptoms may indicate a serious condition.

Keep Out Of Reach Of Children

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

Directions

Single daily dosage (per 24 hours)

 children 2 to under 6 years1 suppository, or as directed by a doctor
 children under 2 yearsconsult a doctor

Other Information

  • carton sealed for safety. If seal with Fleet emblem on bottom flap or top flap is broken or missing, do not use.

Inactive Ingredients

edetate disodium, purified water

Questions?

1-866-255-6960 or www.pedia-lax.com

Package Label.Principal Display Panel

Pedia-lax Liquid Glycerin Suppositories Carton (Pedialaxliquidglycerinsuppositoriescarton)

Pedia-lax Liquid Glycerin Suppositories Carton (Pedialaxliquidglycerinsuppositoriescarton)

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