GENT-L-TIP- mineral oil 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)

Mineral oil 100%

Purpose

Lubricant laxative

Uses

for relief of occasional constipation

Warnings

FOR RECTAL USE ONLY.

Ask a doctor before use if you have

abdominal pain, nausea or vomiting
notice a sudden change in bowel habits that persists over a period of 2 weeks

Stop use and ask a doctor if

you have rectal bleeding or failure to have a bowel movement after use of a laxative because this may indicate a serious condition
you need to use a laxative for more than one week

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

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

Single daily dose

adults & children

12 years and over

1 bottle

children 2 to under

12 years

one-half bottle

children under

2 years

DO NOT USE

How to use this enema:

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 tip into rectum with a slight side-to-side movement, with tip pointing toward navel. Insertion may be easier if person receiving enema bears down, as if having a bowel movement. This helps relax the muscles around the anus.
Do not force the enema tip into rectum as this can cause injury.
Squeeze bottle until nearly all liquid is gone. It is not necessary to empty the bottle completely, as it contains more liquid than needed.
Remove enema tip from rectum.
Retain enema in accordance with doctor's instructions.

Other Information

store at controlled room temperature
this product generally produces a bowel movement in 2-15 minutes

Inactive ingredient

None

Questions or comments?

1-800-367-4477

Side and Principal Display Panel - Box

Gent-l-tip Mineral Oil Enema box principal display panel

NDC 12462-301-04

READY-TO-USE

gent-L-tip

ENEMA

MINERAL OIL

Lubricant laxative
For relief of occasional constipation
Sodium free
Comfortable, lubricated tip

Latex Free

Chester Packaging

4.5 Fl OZ (133 ml)

REODER NO. 101505

Side and Back Panel - Box

GENT-L-TIP
mineral oil enema

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:12462-301
Route of Administration	RECTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	118 g in 118 mL

#	Item Code	Package Description
Packaging
1	NDC:12462-301-04	1 in 1 BOX
1		133 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	01/03/2011	12/31/2017

Labeler - Chester Packaging (004237806)

Revised: 1/2016

Document Id: 2a3ece5e-b661-4a23-e054-00144ff88e88

Set id: 5e238c4c-8369-487c-a9f9-29c40910f8c1

Version: 5

Effective Time: 20160126

Chester Packaging