Label: SALINE LAXATIVE- sodium phosphate enema
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Contains inactivated NDC Code(s)
NDC Code(s): 49348-005-11, 49348-005-35 - Packager: McKesson
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated November 26, 2013
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- Active ingredient
- Purpose
- Uses
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Warnings
For rectal use only
Ask a doctor before use if you have
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- a sodium-restricted diet
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- abdominal pain, nausea or vomiting
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- kidney disease, heart problems, or are dehydrated
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- 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
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- do not use more than directed. Serious side effects may occur from excess dosage.
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- do not use for more than 3 days
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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.
Positioning:
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.
Administering enema:
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- with steady pressure, gently insert enema with tip pointing toward navel.
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- 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).
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- remove tip from rectum
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- 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.
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- maintain position until urge to evacuate is strong (usually 1 to 5 minutes)
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- 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
- Inactive ingredients
- Questions or comments?
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INGREDIENTS AND APPEARANCE
SALINE LAXATIVE
sodium phosphate enemaProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-005 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC 7 g in 118 mL SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, MONOBASIC 19 g in 118 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:49348-005-11 1 in 1 BOX 1 133 mL in 1 BOTTLE 2 NDC:49348-005-35 2 in 1 BOX 2 133 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 08/31/2012 Labeler - McKesson (177667227)
