Ceo Two

Ceo Two
SPL v3
SPL
SPL Set ID 08670636-5795-4db0-e063-6294a90afa4b
Route
RECTAL
Published
Effective Date 2023-10-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Potassium Cation (4.2 g) Bicarbonate Ion (0.9 g)
Inactive Ingredients
Polyethylene Glycol 1450

Identifiers & Packaging

Pill Appearance
Shape: bullet Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-15

Description

Potassium bitartrate, 0.9 g Sodium bicarbonate, 0.6 g

Purpose

Laxative


Medication Information

Purpose

Laxative

Description

Potassium bitartrate, 0.9 g Sodium bicarbonate, 0.6 g

Uses
  • for relief of occasional constipation
  • this product generally produces a bowel movement in 5 to 30 minutes
Section 34076-0
  • each suppository contains:  sodium, 164 mg
Section 50566-9

Rectal bleeding or failure to have a bowel movement after use of a laxative may indicate a serious condition.  Discontinue use and consult your doctor.

Section 50569-3

If you have noticed a sudden change in bowel habits that persists over a period of 2 weeks, consult a doctor before using a laxative

Laxative products should not  be used for a period longer than 1 week unless directed by a doctor

Section 50570-1

Do not use laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor

Do not use this product if you are on a low salt diet unless directed by a doctor

Do not lubricate with mineral oil or petrolatum prior to rectal insertion

Purposes

Laxative

Warnings

For rectal use only

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 ºC (68-77 ºF).  Do not exceed 30 ºC (86 ºF).
  • 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
Active Ingredients

Potassium bitartrate, 0.9 g

Sodium bicarbonate, 0.6 g

Inactive Ingredient

polyethylene glycol

Questions Or Comments?

1-800-238-8542

M-F:  8:00 a.m. - 4:30 p.m. ET

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

Prinicipal Display Panel 54 Count

CEO-TWO Laxative Suppositories

Box of 2:

Box of 6:

Box of 54:


Structured Label Content

Uses
  • for relief of occasional constipation
  • this product generally produces a bowel movement in 5 to 30 minutes
Section 34076-0 (34076-0)
  • each suppository contains:  sodium, 164 mg
Section 50566-9 (50566-9)

Rectal bleeding or failure to have a bowel movement after use of a laxative may indicate a serious condition.  Discontinue use and consult your doctor.

Section 50569-3 (50569-3)

If you have noticed a sudden change in bowel habits that persists over a period of 2 weeks, consult a doctor before using a laxative

Laxative products should not  be used for a period longer than 1 week unless directed by a doctor

Section 50570-1 (50570-1)

Do not use laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor

Do not use this product if you are on a low salt diet unless directed by a doctor

Do not lubricate with mineral oil or petrolatum prior to rectal insertion

Purposes

Laxative

Warnings

For rectal use only

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 (Other information)
  • store at 20-25 ºC (68-77 ºF).  Do not exceed 30 ºC (86 ºF).
  • 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
Active Ingredients (Active ingredients)

Potassium bitartrate, 0.9 g

Sodium bicarbonate, 0.6 g

Inactive Ingredient (Inactive ingredient)

polyethylene glycol

Questions Or Comments? (Questions or comments?)

1-800-238-8542

M-F:  8:00 a.m. - 4:30 p.m. ET

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

Prinicipal Display Panel 54 Count (Prinicipal Display Panel - 54 count)

CEO-TWO Laxative Suppositories

Box of 2:

Box of 6:

Box of 54:


Advanced Ingredient Data


Raw Label Data

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