Label: QUALITY CHOICE SINGLE SALINE LAXATIVE- sodium phosphate, dibasic, unspecified form and sodium phosphate, monobasic, unspecified form enema
- NDC Code(s): 71443-001-06
- Packager: Alcyon Health, 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 July 12, 2017
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Use
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Warnings
For rectal use only
Ask a doctor before use if you
- already used a laxative for more than 1 week
- are dehydrated
- have kidney disease
- are 55 years old or older
- have heart problems
- 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 condition 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?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 133 ml Bottle Carton
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INGREDIENTS AND APPEARANCE
QUALITY CHOICE SINGLE SALINE LAXATIVE
sodium phosphate, dibasic, unspecified form and sodium phosphate, monobasic, unspecified form enemaProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71443-001 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) (SODIUM CATION - UNII:LYR4M0NH37, PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM 7 g in 118 mL SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) (SODIUM CATION - UNII:LYR4M0NH37, PHOSPHATE ION - UNII:NK08V8K8HR) 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:71443-001-06 6 in 1 CARTON 07/05/2017 1 133 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 07/05/2017 Labeler - Alcyon Health, LLC. (080040408) Establishment Name Address ID/FEI Business Operations Natureplex LLC 062808196 MANUFACTURE(71443-001)
