Label: MEDLINE SALINE LAXATIVE FOR CHILDREN- sodium phosphate, dibasic and sodium phosphate, monobasic enema
- NDC Code(s): 53329-015-11
- Packager: Medline Industries, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated March 27, 2014
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- Active ingredient
(in each 59 mL delivered dose)
Dibasic sodium phosphate 3.5 g
Monobasic sodium phosphate 9.5 gClose
- relieves occasional constipation
For rectal use only
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 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.
- do not use 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.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Do not use more unless directed by a doctor. See Warnings.
Children 2 to 11 years
one bottle once daily
do not use
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.
Left-side position: lie on left side with knee bent and arms at rest.
Knee-chest position: kneel, then lower head and chest forward until left side of face is resting on surface. Position arms comfortably.
- 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 59 mL contains: sodium 2.2 g
- store at room temperature 20-25 deg C (68-77 deg F)
- this product generally produces bowel movement in 1 to 5 minutes
- Inactive ingredients
benzalkonium chloride, disodium EDTA, purified waterClose
- Questions or comments?
- Side and Principal Display Panel - box
Pure & Gentle
Comfortable lubricated tip
- Easy to Insert
- Latex free
- Ages 2-11 Years
- 1-2.25 fl oz (66 mL)
- Side and Back - box
- INGREDIENTS AND APPEARANCE
MEDLINE SALINE LAXATIVE FOR CHILDREN
sodium phosphate enema
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-015 Route of Administration RECTAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC 3.5 g in 59 mL SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, MONOBASIC 9.5 g in 59 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-015-11 1 in 1 BOX 1 66 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 03/27/2014 Labeler - Medline Industries, Inc. (025460908)