Label: HEALTHMART SALINE SINGLE LAXATIVE- sodium phosphate, dibasic and sodium phosphate, monobasic, unspecified form enema
- NDC Code(s): 62011-0271-1, 62011-0271-2
- Packager: Strategic Sourcing Services LLC
- 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 January 20, 2022
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Dosage warning: Using more than one enema in 24 hours can be harmful.
For rectal use only.
Ask a doctor before use if you
- have already used a laxative for more than 3 days
- have kidney disease, have heart problems, or are dehydrated
- are 55 years of age or older
- are on a sodium-restricted diet
- have abdominal pain, nausea, or vomiting
- have a sudden change in bowel habits lasting more than 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, without asking a doctor
Stop use and ask a doctor if
- you have rectal bleeding
- 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.
Directions (or as directed by a doctor)
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 of age and older 1 bottle once daily Children 2 to under 12 years of age Use Pediatric Enema Children under 2 years of age DO NOT USE
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton
INGREDIENTS AND APPEARANCE
HEALTHMART SALINE SINGLE LAXATIVE
sodium phosphate, dibasic and sodium phosphate, monobasic, unspecified form enema
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62011-0271 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Phosphate, Dibasic, Unspecified Form (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) Sodium Phosphate, Dibasic, Unspecified Form 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 (UNII: 7FLD91C86K) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62011-0271-1 1 in 1 CARTON 03/20/2012 1 133 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:62011-0271-2 2 in 1 CARTON 03/20/2012 2 133 mL in 1 BOTTLE; 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 03/20/2012 Labeler - Strategic Sourcing Services LLC (116956644) Establishment Name Address ID/FEI Business Operations Natureplex, LLC 062808196 MANUFACTURE(62011-0271)