Label: FREDS SALINE TWIN PACK LAXATIVE- sodium phosphate, dibasic, unspecified form and sodium phosphate, monobasic, unspecified form enema
- NDC Code(s): 55315-301-01
- Packager: FRED'S
- 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 December 26, 2018
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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 3 days
- have kidney disease, have heart problems, or are dehydrated
- are 55 years old or older
- are on a sodium-restricted diet
- have abdominal pain, nausea, or vomiting
- have a sudden change in bowel habits lasing 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
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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 old and older 1 bottle once daily Children 2 to under 12 years old Use Pediatric Enema 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
FREDS SALINE TWIN PACK LAXATIVE
sodium phosphate, dibasic, unspecified form and sodium phosphate, monobasic, unspecified form enemaProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55315-301 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, PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM 7 g in 133 mL SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM 19 g in 133 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:55315-301-01 2 in 1 CARTON 12/20/2019 1 133 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 12/20/2019 Labeler - FRED'S (005866116) Establishment Name Address ID/FEI Business Operations NATUREPLEX LLC 062808196 MANUFACTURE(55315-301)