CEO-TWO- potassium bitartrate and sodium bicarbonate suppository 
Beutlich Pharmaceuticals, LLC

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.

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Drug Facts

Active ingredients

Potassium bitartrate, 0.9 g

Sodium bicarbonate, 0.6 g

Purposes

Laxative

Uses

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 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

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

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.

Other information

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

image of carton

CEO-TWO 
laxative suppository
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0283-0808
Route of Administration RECTAL DEA Schedule     
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
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)

Revised: 3/2015
Document Id: fe0fc90b-8151-4cde-b7b9-461840203417
Set id: d868de56-ac3b-4e44-8aa5-031661f0ac25
Version: 7
Effective Time: 20150312
 
Beutlich Pharmaceuticals, LLC