Label: CEO-TWO- potassium bitartrate and sodium bicarbonate suppository
- 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.
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- Active ingredients
Potassium bitartrate, 0.9 g
Sodium bicarbonate, 0.6 gClose
- for relief of occasional constipation
- this product generally produces a bowel movement in 5 to 30 minutes
For rectal use onlyClose
- Keep out of reach of children
If swallowed, get medical help or contact a poison control center right awayClose
- 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 insertionClose
- 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 doctorClose
- 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.Close
- If pregnant or breast-feeding
ask a health professional before useClose
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.Close
- 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
- Questions or comments?
1-800-238-8542 or 1-847-473-1100
M-F: 8:00 a.m. - 4:30 p.m. CSTClose
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Beutlich Pharmaceuticals, LLC
Waukegan, IL 60085
- INGREDIENTS AND APPEARANCE
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)