Label: CEO-TWO- laxative suppository
0283-0808-36, view more0283-0808-54
- 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.
Updated October 31, 2019
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- Active ingredients
- Keep out of reach of children
- DO NOT USE
- ASK DOCTOR
- STOP USE
- If pregnant or breast-feeding
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
- Other information
- Inactive ingredient
- Questions or comments?
- Prinicipal Display Panel - 54 count
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0283-0808 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM BITARTRATE (UNII: NPT6P8P3UU) (CARBON DIOXIDE - UNII:142M471B3J) CARBON DIOXIDE 927 mg in 3.7 g SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE 618 mg in 3.7 g Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4) 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 08/15/2008 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; Type 0: Not a Combination Product 2 NDC:0283-0808-54 54 in 1 BOX 08/15/2008 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; Type 0: Not a Combination Product 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 Beutlich Pharmaceuticals, LLC 005209325 repack(0283-0808) Establishment Name Address ID/FEI Business Operations Speciality Pharma Manufacturing 013957125 manufacture(0283-0808)