Label: CEO-TWO- potassium bitartrate and sodium bicarbonate 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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 07/13

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

  • Active ingredients

    Potassium bitartrate, 0.9 g

    Sodium bicarbonate, 0.6 g

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  • Purposes

    Laxative

    Laxative

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  • Uses

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

    For rectal use only

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  • Keep out of reach of children

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

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  • 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

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  • 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

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  • 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.

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  • If pregnant or breast-feeding

    ask a health professional before use

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  • 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.

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  • INFORMATION FOR PATIENTS

    • each suppository contains:  sodium, 164 mg
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  • 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
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  • Inactive ingredient

    polyethylene glycol

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  • Questions or comments?

    1-800-238-8542 or 1-847-473-1100

    M-F:  8:00 a.m. - 4:30 p.m. CST

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  • Prinicipal Display Panel - 54 count

    NDC 0283-0808-54

    CEO-TWO

    Laxative´╗┐ Suppositories

    Works within 30 Minutes!

    Manufactured for:

    Beutlich Pharmaceuticals, LLC

    Waukegan, IL 60085

    54 suppositories

    image of carton

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  • INGREDIENTS AND APPEARANCE
    CEO-TWO 
    laxative suppository
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0283-0808
    Route of Administration RECTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POTASSIUM BITARTRATE (CARBON DIOXIDE) CARBON DIOXIDE 927 mg  in 3.7 g
    SODIUM BICARBONATE (SODIUM CATION) SODIUM BICARBONATE 618 mg  in 3.7 g
    Inactive Ingredients
    Ingredient Name Strength
    POLYETHYLENE GLYCOL 1450 2155 mg  in 3.7 g
    Product Characteristics
    Color white Score     
    Shape BULLET Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0283-0808-12 12 in 1 BOX
    1 NDC:0283-0808-36 6 in 1 BOX
    1 NDC:0283-0808-11 2 in 1 BOX
    1 NDC:0283-0808-00 3.7 g in 1 DOSE PACK
    2 NDC:0283-0808-54 54 in 1 BOX
    2 NDC:0283-0808-36 6 in 1 BOX
    2 NDC:0283-0808-11 2 in 1 BOX
    2 NDC:0283-0808-00 3.7 g in 1 DOSE PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 08/15/2008
    Labeler - Beutlich Pharmaceuticals, LLC (005209325)
    Registrant - Beutlich Pharmaceuticals, LLC (005209325)
    Establishment
    Name Address ID/FEI Business Operations
    DSC Laboratories 097807374 manufacture(0283-0808)
    Establishment
    Name Address ID/FEI Business Operations
    Beutlich Pharmaceuticals, LLC 005209325 repack(0283-0808)
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