Label: PRO-ENEMA SINGLE SALINE LAXATIVE- sodium phosphate, dibasic and sodium phosphate, monobasic, unspecified form enema
- NDC Code(s): 71451-001-01
- Packager: Propharma Medical Supplies
- Category: HUMAN OTC DRUG LABEL
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 June 8, 2017
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Use
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Warnings
Ask a doctor before use if you
- already used a laxative for more than 1 week
- have kidney disease
- have heart problems
- are dehydrated
- are 55 years old or older
- are on a sodium-restricted diet
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. 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 bleeding
- the condtion worsens or does not improve within 7 days
- you have no bowel movement within 30 minutes of enema use
- you have symptoms of dehydration (thirstiness, dizziness, vomiting, urinating less often than normal)
These symptoms may indicate a serious condition.
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Directions
Single daily dosage (per 24 hours)
Do not use if taking another sodium phosphate product.
Do not use more unless directed by a doctor. See Warnings.
Adults and children 12 years old and older 1 bottle once daily Children 2 to under 12 years old 1/2 bottle once daily Children under 2 years DO NOT USE - Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
PRO-ENEMA SINGLE SALINE LAXATIVE
sodium phosphate, dibasic and sodium phosphate, monobasic, unspecified form enemaProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71451-001 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Phosphate, Dibasic (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) Sodium Phosphate, Dibasic 7 g in 118 mL SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM 19 g in 118 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71451-001-01 1 in 1 CARTON 06/06/2017 1 133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 06/06/2017 Labeler - Propharma Medical Supplies (558460257)