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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Drug Facts

Active ingredient

(in each 118 mL delivered dose)

Dibasic sodium phosphate 7 g

Monobasic sodium phosphate 19 g

Purpose

Saline laxative

Uses

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:

Other Information

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 Saline Laxative box principal display panel

NDC 12462-201-04

READY-TO-USE

gent-L-tip

ENEMA

SALINE LAXATIVE

Latex Free

Chester Packaging

4.5 Fl OZ (133 ml)

REODER NO. 101503

Side and Back - box

Gent-L-tip Enema Saline Laxative box side and back
GENT-L-TIP 
sodium phosphate enema
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:12462-201
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM PHOSPHATE, DIBASIC (PHOSPHATE ION) SODIUM PHOSPHATE, DIBASIC7 g  in 118 mL
SODIUM PHOSPHATE, MONOBASIC (PHOSPHATE ION) SODIUM PHOSPHATE, MONOBASIC19 g  in 118 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
EDETATE DISODIUM 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12462-201-041 in 1 BOX
1133 mL in 1 BOTTLE
2NDC:12462-201-9145 in 1 CASE
2133 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/03/2011
Labeler - Chester Packaging (004237806)

Revised: 11/2012
Document Id: 7963b73e-2365-4d9f-87bc-6a4990a8ff2b
Set id: 96382762-3d5c-47dd-93d1-b6f0f67e7930
Version: 3
Effective Time: 20121115
 
Chester Packaging