Ceo-two Suppository
FDA Label NDC 0283-1023

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Beutlich Pharmaceuticals, Llc for the product Ceo-two (NDC 0283-1023). 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, purposes, uses, warnings, keep out of reach of children, if pregnant or breast-feeding, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Potassium bitartrate, 0.9 g

Sodium bicarbonate, 0.6 g

Purposes

Laxative

Uses

  • for relief of occasional constipation
  • this product generally produces a bowel movement in 5 to 30 minutes

Warnings

For rectal use only

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a poison control center right away

If Pregnant Or Breast-Feeding

ask a health professional before use

Directions

Adults and children 12 years of age and over:  rectal dosage is one suppository containing 0.6 gram of sodium bicarbonate and 0.9 gram of potassium bitartrate in a single daily dose

Children under 12 years of age:  consult a doctor

Detach one suppository from the strip; remove plastic wrapper.  Moisten suppository by placing it under a water tap for 30 seconds, or in a cup of water for at least 10 seconds, before insertion.  Insert rectally, bulb shape first, past largest diameter of suppository.  Retain suppository as long as possible (usually 10 to 30 minutes) before defecating.

Other Information

  • store at 20-25 °C (68-77 °F).  Do not exceed 30 °C (86 °F).
  • do not refrigerate
  • for your protection, suppositories are individually wrapped in tamper-resistant film.  Do not use if film is torn or open when purchased.
  • save this carton for future reference

Inactive Ingredient

polyethylene glycol

Questions Or Comments?

1-800-238-8542

M-F:  8:00 a.m. - 4:30 p.m. ET

Prinicipal Display Panel - 54 Count

CEO-TWO Laxative Suppositories

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