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

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 or 1-847-473-1100

M-F:  8:00 a.m. - 4:30 p.m. CST

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

CEO-TWO 
laxative suppository
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0283-0808
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM BITARTRATE (CARBON DIOXIDE) CARBON DIOXIDE927 mg  in 3.7 g
SODIUM BICARBONATE (SODIUM CATION) SODIUM BICARBONATE618 mg  in 3.7 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 14502155 mg  in 3.7 g
Product Characteristics
ColorwhiteScore    
ShapeBULLETSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0283-0808-1212 in 1 BOX
1NDC:0283-0808-366 in 1 BOX
1NDC:0283-0808-112 in 1 BOX
1NDC:0283-0808-003.7 g in 1 DOSE PACK
2NDC:0283-0808-5454 in 1 BOX
2NDC:0283-0808-366 in 1 BOX
2NDC:0283-0808-112 in 1 BOX
2NDC:0283-0808-003.7 g in 1 DOSE PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33408/15/2008
Labeler - Beutlich Pharmaceuticals, LLC (005209325)
Registrant - Beutlich Pharmaceuticals, LLC (005209325)
Establishment
NameAddressID/FEIBusiness Operations
DSC Laboratories097807374manufacture(0283-0808)
Establishment
NameAddressID/FEIBusiness Operations
Beutlich Pharmaceuticals, LLC005209325repack(0283-0808)

Revised: 7/2013
Document Id: e6b1907f-3a88-4d16-941a-cf635ca8640c
Set id: d868de56-ac3b-4e44-8aa5-031661f0ac25
Version: 1
Effective Time: 20130712
 
Beutlich Pharmaceuticals, LLC