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| Product NDC Code | 0283-0808 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Ceo-two |
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| Type | Brand | ||||||||
| Pharm Class | Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA] |
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| Active Ingredients |
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| Route | RECTAL | ||||||||
| Dosage Form | SUPPOSITORY | ||||||||
| RxCUI drug identifier | 636185, 636188 |
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| Application Number | M007 | ||||||||
| Labeler Name | Beutlich Pharmaceuticals, LLC | ||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Potassium bitartrate, 0.9 g Sodium bicarbonate, 0.6 g
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredient polyethylene glycol
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses for relief of occasional constipation this product generally produces a bowel movement in 5 to 30 minutes
Purpose
Information about the drug product’s indications for use.Purposes Laxative
Spl product data elements
Usually a list of ingredients in a drug product.CEO-TWO Laxative POLYETHYLENE GLYCOL 1450 POTASSIUM BITARTRATE CARBON DIOXIDE SODIUM BICARBONATE SODIUM CATION
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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
CEO-TWO: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.each suppository contains: sodium, 164 mg
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children If swallowed, get medical help or contact a poison control center right away
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-800-238-8542 M-F: 8:00 a.m. - 4:30 p.m. ET
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding ask a health professional before use
Storage and handling
Information about safe storage and handling of the drug product.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
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For rectal use only
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API