FDA.reportPublic FDA data

CEO-TWO

Manufacturer
Beutlich Pharmaceuticals, LLC | Speciality Pharma Manufacturing
Effective date
2025-11-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:42:18

Label at a glance#

ProductCEO-TWO
Active ingredientPOTASSIUM BITARTRATE, SODIUM BICARBONATE
Label structure15 sections

Indications and uses

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

Dosage and administration

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 ...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Potassium bitartrate, 0.9 g

Sodium bicarbonate, 0.6 g

Purposes

OTC - PURPOSE SECTION

Laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For rectal use only

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - STOP USE SECTION

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.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Directions

DOSAGE & ADMINISTRATION SECTION

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.

INFORMATION FOR PATIENTS SECTION

  • each suppository contains:  sodium, 164 mg

Other information

STORAGE AND HANDLING SECTION

  • 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

Inactive ingredient

INACTIVE INGREDIENT SECTION

polyethylene glycol

Questions or comments?

OTC - QUESTIONS SECTION

1-800-238-8542

M-F:  8:00 a.m. - 4:30 p.m. ET

Prinicipal Display Panel - 54 count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CEO-TWO Laxative Suppositories

Box of 2: 2-count box2-count box

Box of 6: 6-count box6-count box

Box of 54: 54-count box54-count box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
636188CEO-TWO 0.9 GM / 0.6 GM Rectal SuppositoryPSN3
636185potassium bitartrate 0.9 GM / sodium bicarbonate 0.6 GM Rectal SuppositoryPSN3
636188potassium bitartrate 900 MG / sodium bicarbonate 600 MG Rectal Suppository [Ceo-Two]SBD3
636185potassium bitartrate 900 MG / sodium bicarbonate 600 MG Rectal SuppositorySCD3
636188Ceo-Two (potassium bitartrate 0.9 GM / sodium bicarbonate 0.6 GM) Rectal SuppositorySY3
636185K+ bitartrate 900 MG / NaHCO3 600 MG Rectal SuppositorySY3
636188K+ bitartrate 900 MG / NaHCO3 600 MG Rectal Suppository [Ceo-Two]SY3
636185Pot bitartrate 900 MG / NaHCO3 600 MG Rectal SuppositorySY3
636188Pot bitartrate 900 MG / NaHCO3 600 MG Rectal Suppository [Ceo-Two]SY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BICARBONATE ION Pharmacologic Class Indexing1Indexing - Pharmacologic Class20220121
POTASSIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
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f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
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0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
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810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0283-1023-00CEO-TWO5.7 g in 1 DOSE PACKSUPPOSITORY5.73
0283-1023-02CEO-TWO2 in 1 BOXSUPPOSITORY23
0283-1023-36CEO-TWO6 in 1 BOXSUPPOSITORY63
0283-1023-54CEO-TWO54 in 1 BOXSUPPOSITORY543

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0283-1023-02EA - Each0283-1023d7803fbb-22f6-4acb-bdd2-b3da0cb1666712025-08-11
0283-1023-36EA - Each0283-1023299afce1-70d3-4bcd-88c0-09418229861312025-08-11
0283-1023-54EA - Each0283-1023aab567b9-183d-4296-a18e-a6c0a9c6cd3e12025-08-11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0283-10230283-1023-00, 0283-1023-02, 0283-1023-36, 0283-1023-54

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4IACT
POTASSIUM BITARTRATENPT6P8P3UUACTIM
SODIUM BICARBONATE8MDF5V39QOACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-10-28full-release2026-06-01 00:30:49

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CEO-TWOLAXATIVEBeutlich Pharmaceuticals, LLC08670636-5795-4db0-e063-6294a90afa4b2025-11-05WarningsExact identifier
ndc (package): 0283-1023-36
ndc (package): 0283-1023-00
ndc (package): 0283-1023-54
ndc (package): 0283-1023-02
ndc (product): 0283-1023
ndc11 (package): 00283102302
ndc11 (package): 00283102354
ndc11 (package): 00283102300
ndc11 (package): 00283102336
spl id: 42e0774e-b617-290d-e063-6394a90a199e
spl set id: 08670636-5795-4db0-e063-6294a90afa4b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.