Label: READY-TO-USE ENEMA- sodium phosphate enema
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Contains inactivated NDC Code(s)
NDC Code(s): 11673-222-02 - Packager: Target Corporation
- 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 August 23, 2012
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- Official Label (Printer Friendly)
- Active ingredient (in each 118 mL delivered dose)
- Purpose
- Use
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Warnings
For rectal use only
Dosage warning: Using more than one enema in 24 hours can be harmful
Ask a doctor before using any laxative if you have:
- Abdominal pain, nausea, or vomiting
- A sudden change in bowel habits lasting more than 2 weeks
- Already used a laxative for more than 1 week
- When using this product, do not use more than directed.
- Directions
- Other Information
- Inactive Ingredients
- Questions or comments?
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INGREDIENTS AND APPEARANCE
READY-TO-USE ENEMA
sodium phosphate enemaProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-222 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, MONOBASIC 19 g in 118 mL SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC 7 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:11673-222-02 2 in 1 CARTON 1 133 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 08/23/2012 Labeler - Target Corporation (006961700)