CEO-TWO- laxative suppository

CEO-TWO by

Drug Labeling and Warnings

CEO-TWO by is a Otc medication manufactured, distributed, or labeled by Beutlich Pharmaceuticals, LLC, Speciality Pharma Manufacturing. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Potassium bitartrate, 0.9 g

Sodium bicarbonate, 0.6 g

Purposes

Laxative

Uses

• for relief of occasional constipation
• this product generally produces a bowel movement in 5 to 30 minutes

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

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

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 doctor

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.

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.

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

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

CEO-TWO Laxative Suppositories

Box of 2:

Box of 6:

Box of 54:

INGREDIENTS AND APPEARANCE

CEO-TWO 
laxative suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0283-1023
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM BITARTRATE (UNII: NPT6P8P3UU) (CARBON DIOXIDE - UNII:142M471B3J)	CARBON DIOXIDE	0.9 g  in 5.7 g
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	0.6 g  in 5.7 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)	4.2 g  in 5.7 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: 0283-1023-02	2 in 1 BOX	10/15/2023
1	NDC: 0283-1023-00	5.7 g in 1 DOSE PACK; Type 0: Not a Combination Product
2	NDC: 0283-1023-36	6 in 1 BOX	10/15/2023
2	NDC: 0283-1023-00	5.7 g in 1 DOSE PACK; Type 0: Not a Combination Product
3	NDC: 0283-1023-54	54 in 1 BOX	10/15/2023
3	NDC: 0283-1023-00	5.7 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 Drug	M007	10/15/2023

Labeler - Beutlich Pharmaceuticals, LLC (005209325)

Registrant - Beutlich Pharmaceuticals, LLC (005209325)

Establishment
Name	Address	ID/FEI	Business Operations
Beutlich Pharmaceuticals, LLC		005209325	label(0283-1023) , pack(0283-1023)

Establishment
Name	Address	ID/FEI	Business Operations
Speciality Pharma Manufacturing		013957125	manufacture(0283-1023)