Label: CEO-TWO- laxative suppository

  • NDC Code(s): 0283-0808-00, 0283-0808-11, 0283-0808-12, 0283-0808-36, view more
    0283-0808-54
  • Packager: Beutlich Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 31, 2019

If you are a consumer or patient please visit this version.

  • 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

  • DO NOT USE

    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

  • ASK DOCTOR

    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

  • STOP USE

    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

    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.

  • INFORMATION FOR PATIENTS

    • each suppository contains:  sodium, 164 mg
  • 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
  • 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

    NDC 0283-0808-54

    CEO-TWO

    Laxative Suppositories

    Works within 30 Minutes!

    Manufactured for:

    Beutlich Pharmaceuticals, LLC

    Bunnell, FL 32110

    54 suppositories

    Carton 54ct

  • INGREDIENTS AND APPEARANCE
    CEO-TWO 
    laxative suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0283-0808
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM BITARTRATE (UNII: NPT6P8P3UU) (CARBON DIOXIDE - UNII:142M471B3J) CARBON DIOXIDE927 mg  in 3.7 g
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE618 mg  in 3.7 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4) 2155 mg  in 3.7 g
    Product Characteristics
    ColorwhiteScore    
    ShapeBULLETSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0283-0808-1212 in 1 BOX08/15/2008
    1NDC:0283-0808-366 in 1 BOX
    1NDC:0283-0808-112 in 1 BOX
    1NDC:0283-0808-003.7 g in 1 DOSE PACK; Type 0: Not a Combination Product
    2NDC:0283-0808-5454 in 1 BOX08/15/2008
    2NDC:0283-0808-366 in 1 BOX
    2NDC:0283-0808-112 in 1 BOX
    2NDC:0283-0808-003.7 g in 1 DOSE PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33408/15/2008
    Labeler - Beutlich Pharmaceuticals, LLC (005209325)
    Registrant - Beutlich Pharmaceuticals, LLC (005209325)
    Establishment
    NameAddressID/FEIBusiness Operations
    Beutlich Pharmaceuticals, LLC005209325repack(0283-0808)
    Establishment
    NameAddressID/FEIBusiness Operations
    Speciality Pharma Manufacturing013957125manufacture(0283-0808)