GENT-L-TIP - sodium phosphate, dibasic and sodium phosphate, monobasic enema
Chester Packaging

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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Active ingredient

(in each 118 mL delivered dose)

Dibasic sodium phosphate 7 g

Monobasic sodium phosphate 19 g

Purpose

Saline laxative

Uses

relieves occasional constipation

Warnings

For rectal use only

Dosage warning: Using more than one enema in 24 hours can be harmful.

Ask a doctor before use if you have

a sodium-restricted diet
abdominal pain, nausea or vomiting
kidney disease, heart problems, or are dehydrated
noticed a sudden change in bowel habits that lasts over a period of 2 weeks

Ask a doctor or pharmacist before use if you are

taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

When using this product

do not use

more than directed. Serious side effects may occur from excess dosage.
for more than 3 days

Stop use and ask a doctor if

you have rectal bleeding
you have no bowel movement after use of a laxative

These may be signs of a serious condition.

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

Do not use more unless directed by a doctor. See Warnings.

adults & children

12 years and over

one bottle once daily

children 2 to under

12 years

1/2 bottle once daily

children under

2 years

do not use

CAUTION:

Remove green protective shield before inserting. Hold bottle upright, grasping bottle cap with fingers. Grasp protective shield with other hand and pull gently to remove.

Remove protective shield illustration

Positioning:

Left-side position: lie on left side with knee bent and arms at rest.

Left Side position illustration

Knee-chest position: kneel, then lower head and chest forward until left side of face is resting on surface. Position arms comfortably.

Knee-chest position illustration

Administering enema:

with steady pressure, gently insert enema with tip pointing toward navel.
squeeze bottle until recommended dose is expelled (it is not necessary to empty unit completely. Bottle contains more liquid than needed for effective use. A small amount of liquid will remain in bottle after squeezing).
remove tip from rectum
stop using if tip is hard to insert. Forcing the tip into the rectum can cause injury (especially if you have hemorrhoids). If enema tip causes rectal bleeding or pain, get immediate medical care.
maintain position until urge to evacuate is strong (usually 1 to 5 minutes)
if no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor promptly if no liquid comes out of the rectum after 30 minutes because dehydration could occur.

Other Information

each 118 mL contains: sodium 4.3 g
store at controlled room temperature
this product generally produces bowel movement in 1 to 5 minutes

Inactive ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions or comments?

1-800-367-4477

Side and Principal Display Panel - box

gent-L-tip Enema side and PDP panel - box

NDC 12462-201-04

READY-TO-USE

gent-L-tip

ENEMA

SALINE LAXATIVE

Pre-Mixed
For Relief of Occasional Constipation
Lubricated tip

Latex Free

Chester Packaging

4.5 Fl OZ (133 ml)

REODER NO. 101503

Side and Back - box

gent-L-tip Enema side and back panel - box

GENT-L-TIP
sodium phosphate enema

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:12462-201
Route of Administration	RECTAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM PHOSPHATE, DIBASIC (PHOSPHORIC ACID)	SODIUM PHOSPHATE, DIBASIC	7 g in 118 mL
SODIUM PHOSPHATE, MONOBASIC (PHOSPHORIC ACID)	SODIUM PHOSPHATE, MONOBASIC	19 g in 118 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE
EDETATE DISODIUM
WATER

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:12462-201-04	1 BOTTLE in 1 BOX	contains a BOTTLE
1		133 mL in 1 BOTTLE	This package is contained within the BOX (12462-201-04)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	01/03/2011

Labeler - Chester Packaging (004237806)

Revised: 08/2011 Chester Packaging